RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>31722-412-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (31722-412-14) </PackageDescription>
    <NDC11Code>31722-0412-14</NDC11Code>
    <ProductNDC>31722-412</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temozolomide</ProprietaryName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210030</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temozolomide capsule is an alkylating drug indicated for the treatment of adults with:  Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1)   Anaplastic astrocytoma. ( 1.2)       o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2)       o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).</IndicationAndUsage>
    <Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (&lt;5) and labile at pH &gt;7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP.  The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&amp;C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&amp;C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-412-31</NDCCode>
    <PackageDescription>5 CAPSULE in 1 BOTTLE (31722-412-31) </PackageDescription>
    <NDC11Code>31722-0412-31</NDC11Code>
    <ProductNDC>31722-412</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temozolomide</ProprietaryName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210030</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temozolomide capsule is an alkylating drug indicated for the treatment of adults with:  Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1)   Anaplastic astrocytoma. ( 1.2)       o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2)       o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).</IndicationAndUsage>
    <Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (&lt;5) and labile at pH &gt;7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP.  The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&amp;C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&amp;C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21130-412-14</NDCCode>
    <PackageDescription>420 mL in 1 BOTTLE, PLASTIC (21130-412-14)</PackageDescription>
    <NDC11Code>21130-0412-14</NDC11Code>
    <ProductNDC>21130-412</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Safeway</ProprietaryName>
    <ProprietaryNameSuffix>Dandruff Classic Clean</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>SAFEWAY INC.</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>80489-412-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (80489-412-01)  / 14 g in 1 TUBE</PackageDescription>
    <NDC11Code>80489-0412-01</NDC11Code>
    <ProductNDC>80489-412</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Drs Pharmacy Triple Antibiotic Pain Plus Itch Plus Scar</ProprietaryName>
    <NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate Ointment</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210216</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>OL PHARMA TECH, LLC</LabelerName>
    <SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 3.5; 10000; 10</StrengthNumber>
    <StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g; mg/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>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>First aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82249-412-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (82249-412-14) </PackageDescription>
    <NDC11Code>82249-0412-14</NDC11Code>
    <ProductNDC>82249-412</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temozolomide</ProprietaryName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260810</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207658</ApplicationNumber>
    <LabelerName>CivicaScript LLC</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TEMOZOLOMIDE Capsules are an alkylating drug indicated for the treatment of adult patients with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma (1.2)Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
    <Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (&lt;5) and labile at pH &gt;7; hence TEMOZOLOMIDE can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMOZOLOMIDE Capsules, USP. TEMOZOLOMIDE Capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMOZOLOMIDE Capsules, USP 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3.0 mg). , 2 TEMOZOLOMIDE Capsules, USP 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg). , 3 TEMOZOLOMIDE Capsules, USP 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3.0 mg), and stearic acid (6.0 mg). , 4 TEMOZOLOMIDE Capsules, USP 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg). , 5 TEMOZOLOMIDE Capsules, USP 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg). , 6 TEMOZOLOMIDE Capsules, USP 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9.0 mg), and stearic acid (13.5 mg). .</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-411-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (31722-411-14) </PackageDescription>
    <NDC11Code>31722-0411-14</NDC11Code>
    <ProductNDC>31722-411</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temozolomide</ProprietaryName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210030</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temozolomide capsule is an alkylating drug indicated for the treatment of adults with:  Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1)   Anaplastic astrocytoma. ( 1.2)       o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2)       o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).</IndicationAndUsage>
    <Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (&lt;5) and labile at pH &gt;7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP.  The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&amp;C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&amp;C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-413-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (31722-413-14) </PackageDescription>
    <NDC11Code>31722-0413-14</NDC11Code>
    <ProductNDC>31722-413</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temozolomide</ProprietaryName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210030</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temozolomide capsule is an alkylating drug indicated for the treatment of adults with:  Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1)   Anaplastic astrocytoma. ( 1.2)       o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2)       o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).</IndicationAndUsage>
    <Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (&lt;5) and labile at pH &gt;7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP.  The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&amp;C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&amp;C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-414-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (31722-414-14) </PackageDescription>
    <NDC11Code>31722-0414-14</NDC11Code>
    <ProductNDC>31722-414</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temozolomide</ProprietaryName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210030</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>140</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temozolomide capsule is an alkylating drug indicated for the treatment of adults with:  Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1)   Anaplastic astrocytoma. ( 1.2)       o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2)       o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).</IndicationAndUsage>
    <Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (&lt;5) and labile at pH &gt;7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP.  The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&amp;C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&amp;C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-415-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (31722-415-14) </PackageDescription>
    <NDC11Code>31722-0415-14</NDC11Code>
    <ProductNDC>31722-415</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temozolomide</ProprietaryName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210030</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temozolomide capsule is an alkylating drug indicated for the treatment of adults with:  Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1)   Anaplastic astrocytoma. ( 1.2)       o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2)       o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).</IndicationAndUsage>
    <Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (&lt;5) and labile at pH &gt;7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP.  The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&amp;C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&amp;C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-416-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (31722-416-14) </PackageDescription>
    <NDC11Code>31722-0416-14</NDC11Code>
    <ProductNDC>31722-416</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temozolomide</ProprietaryName>
    <NonProprietaryName>Temozolomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210030</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TEMOZOLOMIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temozolomide capsule is an alkylating drug indicated for the treatment of adults with:  Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1)   Anaplastic astrocytoma. ( 1.2)       o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2)       o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).</IndicationAndUsage>
    <Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (&lt;5) and labile at pH &gt;7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP.  The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&amp;C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&amp;C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide.  Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-657-31</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (31722-657-31)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>31722-0657-31</NDC11Code>
    <ProductNDC>31722-657</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dimethyl Fumarate</ProprietaryName>
    <NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210500</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIMETHYL FUMARATE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-05-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off white powder that is slightly soluble in dimethylformamide with a molecular mass of 144.13.  Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&amp;C Blue 1, iron oxide black and iron oxide yellow. The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-680-60</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (31722-680-60)  *  14 CAPSULE, DELAYED RELEASE in 1 BOTTLE *  46 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>31722-0680-60</NDC11Code>
    <ProductNDC>31722-680</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dimethyl Fumarate</ProprietaryName>
    <NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20200924</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210500</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-05-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off white powder that is slightly soluble in dimethylformamide with a molecular mass of 144.13.  Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&amp;C Blue 1, iron oxide black and iron oxide yellow. The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-843-14</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (31722-843-14) </PackageDescription>
    <NDC11Code>31722-0843-14</NDC11Code>
    <ProductNDC>31722-843</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eltrombopag</ProprietaryName>
    <NonProprietaryName>Eltrombopag</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206788</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eltrombopag  tablet is a thrombopoietin receptor agonist indicated:   for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1)  for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag  tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2)  in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3)  for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)  Limitations of Use:   Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4)   Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4).</IndicationAndUsage>
    <Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration.  Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid, ethanolamine. It has the molecular formula C 25H 22N 4O 4.C 4H 14N 2O 2. The molecular weight is 564.27 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:. Eltrombopag olamine is very slightly soluble in methanol and dimethyl formamide. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are:. Tablet Core:magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating:FD&amp;C Blue #2/Indigo carmine aluminum lake (for 25 mg), FD&amp;C Yellow # 6/Sunset Yellow FCF Aluminum lake (for 25 mg), hypromellose, iron oxide yellow (for 75 mg), polyethylene glycol, polysorbate 80 (for 12.5 mg and 75 mg) and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0049-0056-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (0049-0056-60) </PackageDescription>
    <NDC11Code>00049-0056-60</NDC11Code>
    <ProductNDC>0049-0056</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Geodon</ProprietaryName>
    <NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020825</ApplicationNumber>
    <LabelerName>ROERIG</LabelerName>
    <SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
    <Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
  </NDC>
  <NDC>
    <NDCCode>0049-0058-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (0049-0058-60) </PackageDescription>
    <NDC11Code>00049-0058-60</NDC11Code>
    <ProductNDC>0049-0058</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Geodon</ProprietaryName>
    <NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020825</ApplicationNumber>
    <LabelerName>ROERIG</LabelerName>
    <SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
    <Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
  </NDC>
  <NDC>
    <NDCCode>0049-0352-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (0049-0352-60) </PackageDescription>
    <NDC11Code>00049-0352-60</NDC11Code>
    <ProductNDC>0049-0352</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Geodon</ProprietaryName>
    <NonProprietaryName>Ziprasidone</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211108</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020825</ApplicationNumber>
    <LabelerName>ROERIG</LabelerName>
    <SubstanceName>ZIPRASIDONE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
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    <Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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    <IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
    <Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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    <IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
    <Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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    <Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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    <Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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    <Description>GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS · CH3SO3H · 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
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    <Description>Capmatinib is a kinase inhibitor. The chemical name is 2-Fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide—hydrogen chloride—water (1/2/1). The molecular formula for capmatinib dihydrochloride monohydrate is C23H21Cl2FN6O2. The relative molecular mass is 503.36 g/mol for the dihydrochloride monohydrate salt and 412.43 g/mol for the free base. The chemical structure for capmatinib dihydrochloride monohydrate is shown below. Capmatinib dihydrochloride monohydrate is a yellow powder with a pKa1 of 0.9 (calculated) and pKa2 of 4.5 (experimentally). Capmatinib dihydrochloride monohydrate is slightly soluble in acidic aqueous solutions at pH 1 and 2 and of further decreasing solubility towards neutral condition. The log of the distribution coefficient (n-octanol/acetate buffer pH 4.0) is 1.2. TABRECTA is supplied for oral use as ovaloid, curved film-coated tablets with beveled edges, unscored containing 150 mg (pale orange brown color) or 200 mg (yellow color) capmatinib (equivalent to 183.00 mg or 244.00 mg respectively of capmatinib dihydrochloride monohydrate). Each tablet strength contains colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate as inactive ingredients. The 150 mg tablet coating contains ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. The 200 mg tablet coating contains ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide.</Description>
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    <Description>Capmatinib is a kinase inhibitor. The chemical name is 2-Fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide—hydrogen chloride—water (1/2/1). The molecular formula for capmatinib dihydrochloride monohydrate is C23H21Cl2FN6O2. The relative molecular mass is 503.36 g/mol for the dihydrochloride monohydrate salt and 412.43 g/mol for the free base. The chemical structure for capmatinib dihydrochloride monohydrate is shown below. Capmatinib dihydrochloride monohydrate is a yellow powder with a pKa1 of 0.9 (calculated) and pKa2 of 4.5 (experimentally). Capmatinib dihydrochloride monohydrate is slightly soluble in acidic aqueous solutions at pH 1 and 2 and of further decreasing solubility towards neutral condition. The log of the distribution coefficient (n-octanol/acetate buffer pH 4.0) is 1.2. TABRECTA is supplied for oral use as ovaloid, curved film-coated tablets with beveled edges, unscored containing 150 mg (pale orange brown color) or 200 mg (yellow color) capmatinib (equivalent to 183.00 mg or 244.00 mg respectively of capmatinib dihydrochloride monohydrate). Each tablet strength contains colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate as inactive ingredients. The 150 mg tablet coating contains ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. The 200 mg tablet coating contains ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide.</Description>
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    <Description>Capmatinib is a kinase inhibitor. The chemical name is 2-Fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide—hydrogen chloride—water (1/2/1). The molecular formula for capmatinib dihydrochloride monohydrate is C23H21Cl2FN6O2. The relative molecular mass is 503.36 g/mol for the dihydrochloride monohydrate salt and 412.43 g/mol for the free base. The chemical structure for capmatinib dihydrochloride monohydrate is shown below. Capmatinib dihydrochloride monohydrate is a yellow powder with a pKa1 of 0.9 (calculated) and pKa2 of 4.5 (experimentally). Capmatinib dihydrochloride monohydrate is slightly soluble in acidic aqueous solutions at pH 1 and 2 and of further decreasing solubility towards neutral condition. The log of the distribution coefficient (n-octanol/acetate buffer pH 4.0) is 1.2. TABRECTA is supplied for oral use as ovaloid, curved film-coated tablets with beveled edges, unscored containing 150 mg (pale orange brown color) or 200 mg (yellow color) capmatinib (equivalent to 183.00 mg or 244.00 mg respectively of capmatinib dihydrochloride monohydrate). Each tablet strength contains colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate as inactive ingredients. The 150 mg tablet coating contains ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide. The 200 mg tablet coating contains ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide.</Description>
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    <LastUpdate>2025-12-01</LastUpdate>
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    <Description>Ziprasidone capsules, USP are an atypical antipsychotic available for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a monohydrochloride, anhydrous salt of ziprasidone. Chemically, ziprasidone hydrochloride anhydrous is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, anhydrous. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.4. Ziprasidone hydrochloride anhydrous is a light pink to dark pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (yellow/blue), 40 mg (blue/blue), 60 mg (yellow/yellow), and 80 mg (yellow/blue) capsules. Ziprasidone capsule, USP intended for oral administration, contains ziprasidone hydrochloride anhydrous equivalent to 20 mg, 40 mg, 60 mg or 80 mg of ziprasidone. In addition, each capsule contains the following inactive ingredients: calcium silicate, citric acid, lactose anhydrous, magnesium stearate and pregelatinized starch. The capsule shell for the 20 mg and 80 mg strengths consists of carboxymethylcellulose, FD&amp;C blue # 2, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The capsule shell for the 40 mg strength consists of FD&amp;C blue # 2, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible white pharmaceutical ink. The capsule shell for the 60 mg strength consists of carboxymethylcellulose, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The black ink is comprised of iron oxide black, potassium hydroxide, propylene glycol, shellac and ammonia solution. The white ink is comprised of povidone, propylene glycol, sodium hydroxide, shellac and titanium dioxide.</Description>
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    <Description>Ziprasidone capsules, USP are an atypical antipsychotic available for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a monohydrochloride, anhydrous salt of ziprasidone. Chemically, ziprasidone hydrochloride anhydrous is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, anhydrous. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.4. Ziprasidone hydrochloride anhydrous is a light pink to dark pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (yellow/blue), 40 mg (blue/blue), 60 mg (yellow/yellow), and 80 mg (yellow/blue) capsules. Ziprasidone capsule, USP intended for oral administration, contains ziprasidone hydrochloride anhydrous equivalent to 20 mg, 40 mg, 60 mg or 80 mg of ziprasidone. In addition, each capsule contains the following inactive ingredients: calcium silicate, citric acid, lactose anhydrous, magnesium stearate and pregelatinized starch. The capsule shell for the 20 mg and 80 mg strengths consists of carboxymethylcellulose, FD&amp;C blue # 2, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The capsule shell for the 40 mg strength consists of FD&amp;C blue # 2, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible white pharmaceutical ink. The capsule shell for the 60 mg strength consists of carboxymethylcellulose, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The black ink is comprised of iron oxide black, potassium hydroxide, propylene glycol, shellac and ammonia solution. The white ink is comprised of povidone, propylene glycol, sodium hydroxide, shellac and titanium dioxide.</Description>
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    <Description>Ziprasidone capsules, USP are an atypical antipsychotic available for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a monohydrochloride, anhydrous salt of ziprasidone. Chemically, ziprasidone hydrochloride anhydrous is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, anhydrous. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.4. Ziprasidone hydrochloride anhydrous is a light pink to dark pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (yellow/blue), 40 mg (blue/blue), 60 mg (yellow/yellow), and 80 mg (yellow/blue) capsules. Ziprasidone capsule, USP intended for oral administration, contains ziprasidone hydrochloride anhydrous equivalent to 20 mg, 40 mg, 60 mg or 80 mg of ziprasidone. In addition, each capsule contains the following inactive ingredients: calcium silicate, citric acid, lactose anhydrous, magnesium stearate and pregelatinized starch. The capsule shell for the 20 mg and 80 mg strengths consists of carboxymethylcellulose, FD&amp;C blue # 2, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The capsule shell for the 40 mg strength consists of FD&amp;C blue # 2, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible white pharmaceutical ink. The capsule shell for the 60 mg strength consists of carboxymethylcellulose, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The black ink is comprised of iron oxide black, potassium hydroxide, propylene glycol, shellac and ammonia solution. The white ink is comprised of povidone, propylene glycol, sodium hydroxide, shellac and titanium dioxide.</Description>
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    <ApplicationNumber>ANDA077562</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130213</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1 Ziprasidone is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
    <Description>Ziprasidone capsules, USP are an atypical antipsychotic available for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a monohydrochloride, anhydrous salt of ziprasidone. Chemically, ziprasidone hydrochloride anhydrous is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, anhydrous. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.4. Ziprasidone hydrochloride anhydrous is a light pink to dark pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (yellow/blue), 40 mg (blue/blue), 60 mg (yellow/yellow), and 80 mg (yellow/blue) capsules. Ziprasidone capsule, USP intended for oral administration, contains ziprasidone hydrochloride anhydrous equivalent to 20 mg, 40 mg, 60 mg or 80 mg of ziprasidone. In addition, each capsule contains the following inactive ingredients: calcium silicate, citric acid, lactose anhydrous, magnesium stearate and pregelatinized starch. The capsule shell for the 20 mg and 80 mg strengths consists of carboxymethylcellulose, FD&amp;C blue # 2, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The capsule shell for the 40 mg strength consists of FD&amp;C blue # 2, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible white pharmaceutical ink. The capsule shell for the 60 mg strength consists of carboxymethylcellulose, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The black ink is comprised of iron oxide black, potassium hydroxide, propylene glycol, shellac and ammonia solution. The white ink is comprised of povidone, propylene glycol, sodium hydroxide, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-6269-08</NDCCode>
    <PackageDescription>40 BLISTER PACK in 1 CARTON (0904-6269-08)  / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-6269-08</NDC11Code>
    <ProductNDC>0904-6269</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ziprasidone</ProprietaryName>
    <NonProprietaryName>Ziprasidone</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077565</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1  Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
    <Description>Ziprasidone capsules, USP contains the active moiety, ziprasidone in the form of ziprasidone hydrochloride, USP salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a hydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride USP is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, hydrochloride. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.40. Ziprasidone hydrochloride USP is a light pink to pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride USP, anhydrous lactose, magnesium stearate, polysorbate 80, povidone (PVK-30), pregelatinized starch and silicon dioxide. The components of the capsule shells are FD&amp;C Blue #1, FD&amp;C Red #3, gelatin, red iron oxide and titanium dioxide. The capsule shells are imprinted with black ink. The components of black ink (Black SW-9008/SW-9009) are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Ziprasidone capsules meets USP Dissolution Test 3.</Description>
  </NDC>
</NDCList>