RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>68001-478-46</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68001-478-46)  &gt; 14.2 g in 1 TUBE</PackageDescription>
    <NDC11Code>68001-0478-46</NDC11Code>
    <ProductNDC>68001-478</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antifungal Cream</ProprietaryName>
    <NonProprietaryName>Antifungal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201125</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55670-478-50</NDCCode>
    <PackageDescription>50 PACKET in 1 BOX (55670-478-50)  &gt; 1 TABLET, FILM COATED in 1 PACKET (55670-478-46) </PackageDescription>
    <NDC11Code>55670-0478-50</NDC11Code>
    <ProductNDC>55670-478</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Moore Medical Loratadine</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081230</StartMarketingDate>
    <EndMarketingDate>20211130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076134</ApplicationNumber>
    <LabelerName>Moore Medical LLC</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20081230</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68001-478-45</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68001-478-45)  &gt; 28.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>68001-0478-45</NDC11Code>
    <ProductNDC>68001-478</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antifungal Cream</ProprietaryName>
    <NonProprietaryName>Antifungal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201125</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68001-475-46</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68001-475-46)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>68001-0475-46</NDC11Code>
    <ProductNDC>68001-475</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antifungal Cream</ProprietaryName>
    <NonProprietaryName>Antifungal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201125</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>CLOTRIMAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68001-476-46</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68001-476-46)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>68001-0476-46</NDC11Code>
    <ProductNDC>68001-476</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Antipruritic (anti-itch)</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201127</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201127</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68001-477-46</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68001-477-46)  / 14.2 g in 1 TUBE</PackageDescription>
    <NDC11Code>68001-0477-46</NDC11Code>
    <ProductNDC>68001-477</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bacitracin</ProprietaryName>
    <NonProprietaryName>Bacitracin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201124</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>BACITRACIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[iU]/g</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Synthesis &amp; Repair [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>deep or puncture wounds, animal bites, or serious burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68001-483-46</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68001-483-46)  / 14.2 g in 1 TUBE</PackageDescription>
    <NDC11Code>68001-0483-46</NDC11Code>
    <ProductNDC>68001-483</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triple Antibiotic</ProprietaryName>
    <NonProprietaryName>First Aid Antibiotic</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210615</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE; BACITRACIN ZINC; POLYMYXIN B SULFATE</SubstanceName>
    <StrengthNumber>3.5; 400; 5000</StrengthNumber>
    <StrengthUnit>mg/g; [iU]/g; [iU]/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis &amp; Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First Aid to help prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68001-531-46</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68001-531-46)  / 28.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>68001-0531-46</NDC11Code>
    <ProductNDC>68001-531</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bacitracin Zinc</ProprietaryName>
    <NonProprietaryName>First Aid Antibiotic</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220304</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>BACITRACIN ZINC</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[USP'U]/g</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Synthesis &amp; Repair [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68001-532-46</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68001-532-46)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>68001-0532-46</NDC11Code>
    <ProductNDC>68001-532</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zinc Oxide</ProprietaryName>
    <NonProprietaryName>Skin Protectant</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220324</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-11-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> Dries the oozing and weeping of poison:  Ivy  Oak  Sumac.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68001-622-05</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68001-622-05) </PackageDescription>
    <NDC11Code>68001-0622-05</NDC11Code>
    <ProductNDC>68001-622</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Imatinib Mesylate</ProprietaryName>
    <NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212773</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>IMATINIB MESYLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. ( 1.4) , 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). ( 1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. ( 1.10) .</IndicationAndUsage>
    <Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-‑1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a white to pale yellow color powder. Its molecular formula is C 29H 31N 7O  CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is freely soluble in dimethyl sulphoxide, soluble in water and sparingly soluble in methanol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-623-04</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68001-623-04) </PackageDescription>
    <NDC11Code>68001-0623-04</NDC11Code>
    <ProductNDC>68001-623</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Imatinib Mesylate</ProprietaryName>
    <NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212773</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>IMATINIB MESYLATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. ( 1.4) , 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). ( 1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. ( 1.10) .</IndicationAndUsage>
    <Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-‑1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a white to pale yellow color powder. Its molecular formula is C 29H 31N 7O  CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is freely soluble in dimethyl sulphoxide, soluble in water and sparingly soluble in methanol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>25357-024-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (25357-024-01)  *  1 SYRINGE, GLASS in 1 POUCH (25357-026-01)  / 2 mL in 1 SYRINGE, GLASS *  1 SYRINGE, GLASS in 1 POUCH (25357-027-01)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>25357-0024-01</NDC11Code>
    <ProductNDC>25357-024</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epioxa Cross-linking</ProprietaryName>
    <NonProprietaryName>Riboflavin 5-phosphate Ophthalmic</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20260116</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219910</ApplicationNumber>
    <LabelerName>Glaukos Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>EPIOXA HD and EPIOXA are indicated in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O2n System and the Boost Goggles.</IndicationAndUsage>
    <Description>EPIOXA HD (riboflavin 5'-phosphate ophthalmic solution) 0.239% and EPIOXA (riboflavin 5'-phosphate ophthalmic solution) 0.177% contain riboflavin 5'-phosphate, a photoenhancer, for topical ophthalmic use. EPIOXA HD 0.239% is a clear, yellow, sterile buffered solution containing 2.39 mg/mL riboflavin 5'-phosphate. The pH of the solution is 6.7 to 7.7 and the osmolality is 200 mOsm/kg to 260 mOsm/kg. Each mL of solution contains 2.50 mg of riboflavin 5'-phosphate sodium (equivalent to 1.97 mg/mL riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are hydroxypropyl methylcellulose, sodium chloride, dibasic sodium phosphate dihydrate, edetate disodium dihydrate, tromethamine, monobasic sodium phosphate dihydrate, benzalkonium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. EPIOXA 0.177% is a clear, yellow, sterile buffered solution containing 1.77 mg/mL riboflavin 5'-phosphate. The pH of the solution is 6.5 to 7.5 and the osmolality is 330 mOsm/kg to 400 mOsm/kg. Each mL of solution contains 1.85 mg of riboflavin 5'-phosphate sodium (equivalent to 1.46 mg/mL riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are sodium chloride, dibasic sodium phosphate dihydrate, tromethamine, monobasic sodium phosphate dihydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The molecular formula for riboflavin 5'-phosphate sodium (Vitamin B2) is C17H20N4NaO9P with a molecular weight of 478.33 g/mol.</Description>
  </NDC>
  <NDC>
    <NDCCode>25357-025-03</NDCCode>
    <PackageDescription>2 POUCH in 1 BOX (25357-025-03)  / 1 POUCH in 1 POUCH / 1 SYRINGE, GLASS in 1 POUCH / 1 KIT in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>25357-0025-03</NDC11Code>
    <ProductNDC>25357-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Photrexa Cross-linking Kit</ProprietaryName>
    <NonProprietaryName>Riboflavin 5-phosphate Ophthalmic</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20170925</StartMarketingDate>
    <EndMarketingDate>20290731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203324</ApplicationNumber>
    <LabelerName>Glaukos Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170925</StartMarketingDatePackage>
    <EndMarketingDatePackage>20290731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PHOTREXA® VISCOUS and PHOTREXA® are indicated for use in corneal collagen cross-linking in combination with the KXL® System for the treatment of.</IndicationAndUsage>
    <Description>PHOTREXA VISCOUS (riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% and PHOTREXA (riboflavin 5'-phosphate ophthalmic solution) 0.146% are intended for topical ophthalmic administration as part of corneal collagen cross-linking with the KXL System. PHOTREXA VISCOUS and PHOTREXA are supplied as. PHOTREXA VISCOUS (riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% is a yellow sterile buffered viscous solution containing 1.56 mg/mL riboflavin 5'-phosphate and 20% dextran. The pH of the solution is approximately 7.1 and the osmolality is 284-368 mOsm/kg. Each 1 mL of solution contains 1.64 mg of riboflavin 5'-phosphate sodium (equivalent to 1.284 mg riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate dihydrate, dextran, monobasic sodium phosphate dihydrate, sodium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. PHOTREXA (riboflavin 5'-phosphate ophthalmic solution) 0.146% is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate. The pH of the solution is approximately 7.1 and the osmolality is 157-181 mOsm/kg. Each 1 mL of solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivalent to 1.20 mg riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate dihydrate, monobasic sodium phosphate dihydrate, sodium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The chemical formula for riboflavin 5'-phosphate sodium (Vitamin B2) is C17H20N4NaO9P with a molecular mass of 478.33 g/mol. Please refer to the KXL System Operator's Manual for a specific device description and instructions.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-478-03</NDCCode>
    <PackageDescription>3 POUCH in 1 CARTON (42291-478-03)  / 21 d in 1 POUCH (42291-478-11) </PackageDescription>
    <NDC11Code>42291-0478-03</NDC11Code>
    <ProductNDC>42291-478</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Etonogestrel And Ethinyl Estradiol Vaginal</ProprietaryName>
    <NonProprietaryName>Etonogestrel And Ethinyl Estradiol Vaginal</NonProprietaryName>
    <DosageFormName>RING</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20230921</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211157</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>ETHINYL ESTRADIOL; ETONOGESTREL</SubstanceName>
    <StrengthNumber>.015; .12</StrengthNumber>
    <StrengthUnit>mg/d; mg/d</StrengthUnit>
    <Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FOR VAGINAL USE ONLY Etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy.</IndicationAndUsage>
    <Description>Etonogestrel and ethinyl estradiol vaginal ring is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Etonogestrel and ethinyl estradiol vaginal ring is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Etonogestrel and ethinyl estradiol vaginal ring is not made with natural rubber latex. Etonogestrel and ethinyl estradiol vaginal ring has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>66116-478-20</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (66116-478-20)</PackageDescription>
    <NDC11Code>66116-0478-20</NDC11Code>
    <ProductNDC>66116-478</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
    <NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065096</ApplicationNumber>
    <LabelerName>MedVantx, Inc.</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
    <StrengthNumber>875; 125</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Amoxicillin and clavulanate potassium tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below.</IndicationAndUsage>
    <Description>Amoxicillin and clavulanate potassium tablets USP are an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and has the following structural formula. C16H19N3O5S3H2O M.W. 419.46. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula. C8H8KNO5 M.W. 237.25. Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each amoxicillin and clavulanate potassium tablet USP contains 0.63 mEq potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-231-06</NDCCode>
    <PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-231-06) </PackageDescription>
    <NDC11Code>68001-0231-06</NDC11Code>
    <ProductNDC>68001-231</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201089</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
    <StrengthNumber>50; 200</StrengthNumber>
    <StrengthUnit>mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3)].</IndicationAndUsage>
    <Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, USP a NSAID with analgesic properties, and misoprostol, USP a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex tablets, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg or 75 mg diclofenac sodium, USP (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 0.2 mg misoprostol, USP. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are:. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol, USP is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide, crospovidone, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone K-30, sodium hydroxide, corn starch, talc, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-232-06</NDCCode>
    <PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-232-06) </PackageDescription>
    <NDC11Code>68001-0232-06</NDC11Code>
    <ProductNDC>68001-232</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201089</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
    <StrengthNumber>75; 200</StrengthNumber>
    <StrengthUnit>mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3)].</IndicationAndUsage>
    <Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, USP a NSAID with analgesic properties, and misoprostol, USP a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex tablets, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg or 75 mg diclofenac sodium, USP (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 0.2 mg misoprostol, USP. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are:. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol, USP is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide, crospovidone, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone K-30, sodium hydroxide, corn starch, talc, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0401-34</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (0078-0401-34) </PackageDescription>
    <NDC11Code>00078-0401-34</NDC11Code>
    <ProductNDC>0078-0401</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gleevec</ProprietaryName>
    <NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010515</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021588</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>IMATINIB MESYLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gleevec is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
    <Description>Imatinib is a small molecule kinase inhibitor. Gleevec film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O  CH4SO3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide (NF); crospovidone (NF); hydroxypropyl methylcellulose (USP); magnesium stearate (NF); and microcrystalline cellulose (NF). Tablet coating: ferric oxide, red (NF); ferric oxide, yellow (NF); hydroxypropyl methylcellulose (USP); polyethylene glycol (NF), and talc (USP).</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0649-13</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (0078-0649-13)  / 10 TABLET in 1 BLISTER PACK (0078-0649-26) </PackageDescription>
    <NDC11Code>00078-0649-13</NDC11Code>
    <ProductNDC>0078-0649</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gleevec</ProprietaryName>
    <NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021588</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>IMATINIB MESYLATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gleevec is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
    <Description>Imatinib is a small molecule kinase inhibitor. Gleevec film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O  CH4SO3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide (NF); crospovidone (NF); hydroxypropyl methylcellulose (USP); magnesium stearate (NF); and microcrystalline cellulose (NF). Tablet coating: ferric oxide, red (NF); ferric oxide, yellow (NF); hydroxypropyl methylcellulose (USP); polyethylene glycol (NF), and talc (USP).</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0649-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30) </PackageDescription>
    <NDC11Code>00078-0649-30</NDC11Code>
    <ProductNDC>0078-0649</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gleevec</ProprietaryName>
    <NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021588</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>IMATINIB MESYLATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141223</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <Description>Imatinib is a small molecule kinase inhibitor. Gleevec film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O  CH4SO3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide (NF); crospovidone (NF); hydroxypropyl methylcellulose (USP); magnesium stearate (NF); and microcrystalline cellulose (NF). Tablet coating: ferric oxide, red (NF); ferric oxide, yellow (NF); hydroxypropyl methylcellulose (USP); polyethylene glycol (NF), and talc (USP).</Description>
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    <Description>Imatinib is a small molecule kinase inhibitor. Gleevec film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O  CH4SO3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide (NF); crospovidone (NF); hydroxypropyl methylcellulose (USP); magnesium stearate (NF); and microcrystalline cellulose (NF). Tablet coating: ferric oxide, red (NF); ferric oxide, yellow (NF); hydroxypropyl methylcellulose (USP); polyethylene glycol (NF), and talc (USP).</Description>
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    <Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is a white to off-white to brownish or yellowish powder. Its molecular formula is C29H31N7O  CH4SO3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide anhydrous, croscarmellose sodium, crospovidone, FD&amp;C Yellow #6 Sunset Yellow FCF aluminum lake, hydroxypropyl cellulose, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide.</Description>
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    <Description>Niraparib is an orally available poly (ADP-ribose) polymerase (PARP) inhibitor. The chemical name for niraparib tosylate monohydrate is 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole 7-carboxamide 4-methylbenzenesulfonate hydrate (1:1:1). The molecular formula is C26H30N4O5S and it has a molecular weight of 510.61 amu. The molecular structure is shown below. Niraparib tosylate monohydrate is a white to off-white, non-hygroscopic crystalline solid. Niraparib solubility is pH independent below the pKa of 9.95, with an aqueous free base solubility of 0.7 mg/mL to 1.1 mg/mL across the physiological pH range. Each ZEJULA tablet contains 159.3 mg, 318.7 mg, or 478.0 mg of niraparib tosylate monohydrate equivalent to 100 mg, 200 mg, or 300 mg, respectively, of niraparib free base as the active ingredient. The inactive ingredients in the core tablet are crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and silicon dioxide. The film-coating consists of Opadry II Gray (100 mg), Opadry II Blue (200 mg), or Opadry II Green (300 mg).</Description>
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    <Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: : 1 for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:oa deleterious or suspected deleterious BRCA mutation, and/orogenomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. (1.1, 2.1), 2 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. (1.2, 2.1).</IndicationAndUsage>
    <Description>Niraparib is an orally available poly (ADP-ribose) polymerase (PARP) inhibitor. The chemical name for niraparib tosylate monohydrate is 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole 7-carboxamide 4-methylbenzenesulfonate hydrate (1:1:1). The molecular formula is C26H30N4O5S and it has a molecular weight of 510.61 amu. The molecular structure is shown below. Niraparib tosylate monohydrate is a white to off-white, non-hygroscopic crystalline solid. Niraparib solubility is pH independent below the pKa of 9.95, with an aqueous free base solubility of 0.7 mg/mL to 1.1 mg/mL across the physiological pH range. Each ZEJULA tablet contains 159.3 mg, 318.7 mg, or 478.0 mg of niraparib tosylate monohydrate equivalent to 100 mg, 200 mg, or 300 mg, respectively, of niraparib free base as the active ingredient. The inactive ingredients in the core tablet are crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and silicon dioxide. The film-coating consists of Opadry II Gray (100 mg), Opadry II Blue (200 mg), or Opadry II Green (300 mg).</Description>
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    <NDCCode>0173-0915-61</NDCCode>
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    <ProductNDC>0173-0915</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zejula</ProprietaryName>
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    <RouteName>ORAL</RouteName>
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    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214876</ApplicationNumber>
    <LabelerName>GlaxoSmithKline LLC</LabelerName>
    <SubstanceName>NIRAPARIB TOSYLATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
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    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230627</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: : 1 for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:oa deleterious or suspected deleterious BRCA mutation, and/orogenomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. (1.1, 2.1), 2 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. (1.2, 2.1).</IndicationAndUsage>
    <Description>Niraparib is an orally available poly (ADP-ribose) polymerase (PARP) inhibitor. The chemical name for niraparib tosylate monohydrate is 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole 7-carboxamide 4-methylbenzenesulfonate hydrate (1:1:1). The molecular formula is C26H30N4O5S and it has a molecular weight of 510.61 amu. The molecular structure is shown below. Niraparib tosylate monohydrate is a white to off-white, non-hygroscopic crystalline solid. Niraparib solubility is pH independent below the pKa of 9.95, with an aqueous free base solubility of 0.7 mg/mL to 1.1 mg/mL across the physiological pH range. Each ZEJULA tablet contains 159.3 mg, 318.7 mg, or 478.0 mg of niraparib tosylate monohydrate equivalent to 100 mg, 200 mg, or 300 mg, respectively, of niraparib free base as the active ingredient. The inactive ingredients in the core tablet are crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and silicon dioxide. The film-coating consists of Opadry II Gray (100 mg), Opadry II Blue (200 mg), or Opadry II Green (300 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>0363-0540-01</NDCCode>
    <PackageDescription>118 mL in 1 PACKAGE (0363-0540-01)</PackageDescription>
    <NDC11Code>00363-0540-01</NDC11Code>
    <ProductNDC>0363-0540</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hydrating Antioxidant Moiturizer</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171028</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Walgreen Company</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>2.478; 4.72; 4.72; 2.36</StrengthNumber>
    <StrengthUnit>g/118mL; g/118mL; g/118mL; 1/118mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses  helps prevent sunburn  If used as directed. with other protection measures (see. Directions), decreases the risk of skin cancer and. early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0378-2245-77</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2245-77) </PackageDescription>
    <NDC11Code>00378-2245-77</NDC11Code>
    <ProductNDC>0378-2245</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Imatinib Mesylate</ProprietaryName>
    <NonProprietaryName>Imatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170928</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204644</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>IMATINIB MESYLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170928</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
    <Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg or 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as Benzamide, 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]aminophenyl]-methanesulfonate salt and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O  CH4SO3 and its molecular weight is 589.71 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide and yellow iron oxide.</Description>
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