RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>71610-488-53</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (71610-488-53) </PackageDescription>
    <NDC11Code>71610-0488-53</NDC11Code>
    <ProductNDC>71610-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040702</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in pregnancyRoutine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
    <Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg of hydrochlorothiazide USP respectively. In addition, each tablet contains the following inactive ingredients: FD&amp;C yellow #6, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-488-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (71610-488-60) </PackageDescription>
    <NDC11Code>71610-0488-60</NDC11Code>
    <ProductNDC>71610-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040702</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in pregnancyRoutine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
    <Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg of hydrochlorothiazide USP respectively. In addition, each tablet contains the following inactive ingredients: FD&amp;C yellow #6, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-488-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (71610-488-15) </PackageDescription>
    <NDC11Code>71610-0488-15</NDC11Code>
    <ProductNDC>71610-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040702</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in pregnancyRoutine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
    <Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg of hydrochlorothiazide USP respectively. In addition, each tablet contains the following inactive ingredients: FD&amp;C yellow #6, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-488-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (71610-488-30) </PackageDescription>
    <NDC11Code>71610-0488-30</NDC11Code>
    <ProductNDC>71610-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040702</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in pregnancyRoutine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
    <Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg of hydrochlorothiazide USP respectively. In addition, each tablet contains the following inactive ingredients: FD&amp;C yellow #6, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-488-45</NDCCode>
    <PackageDescription>45 TABLET in 1 BOTTLE, PLASTIC (71610-488-45) </PackageDescription>
    <NDC11Code>71610-0488-45</NDC11Code>
    <ProductNDC>71610-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040702</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in pregnancyRoutine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
    <Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg of hydrochlorothiazide USP respectively. In addition, each tablet contains the following inactive ingredients: FD&amp;C yellow #6, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-488-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (16590-488-60)</PackageDescription>
    <NDC11Code>16590-0488-60</NDC11Code>
    <ProductNDC>16590-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Etodolac</ProprietaryName>
    <NonProprietaryName>Etodolac</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19980430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075078</ApplicationNumber>
    <LabelerName>STAT Rx USA LLC</LabelerName>
    <SubstanceName>ETODOLAC</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
    <Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Polyethylene Glycol, Povidone USP, Sodium Starch Glycolate NF and Titanium Dioxide. Also, each 400 mg tablet contains Iron Oxide Red and Iron Oxide Yellow. Each 500 mg tablet contains D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, and FD&amp;C Red #40 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-488-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (21695-488-60)</PackageDescription>
    <NDC11Code>21695-0488-60</NDC11Code>
    <ProductNDC>21695-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Enalapril Maleate</ProprietaryName>
    <NonProprietaryName>Enalapril Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075483</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>ENALAPRIL MALEATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <Description>Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as L-Proline,1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]- , (S)-, (Z)-2-butenedioate (1:1). Its molecular formula is, C. 20. H. 28. N. 2. O. 5. ·C. 4. H. 4. O. 4. , and its structural formula is. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor. Enalapril maleate is supplied as 2.5 mg, 5 mg,10 mg and 20 mg tablets for oral administration. In addition, each tablet contains the following inactive ingredients: hypromellose, anhydrous lactose, corn starch, stearic acid and talc. The 10 mg and 20 mg tablets also contain iron oxides.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-488-09</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-488-09) </PackageDescription>
    <NDC11Code>33342-0488-09</NDC11Code>
    <ProductNDC>33342-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rivaroxaban</ProprietaryName>
    <NonProprietaryName>Rivaroxaban</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213114</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RIVAROXABAN</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250514</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated:  to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7)  to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).</IndicationAndUsage>
    <Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban USP is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban tablets, USP contains 2.5 mg of rivaroxaban. The inactive ingredients of Rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablet, USP 2.5 mg is Instacoat@ Yellow and containing Hypromellose, polyethylene glycol, Titanium dioxide, yellow iron oxide. USP Dissolution test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-488-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-488-60) </PackageDescription>
    <NDC11Code>60760-0488-60</NDC11Code>
    <ProductNDC>60760-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140116</StartMarketingDate>
    <EndMarketingDate>20190531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077455</ApplicationNumber>
    <LabelerName>St Marys Medical Park Pharmacy</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140116</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71205-488-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (71205-488-60) </PackageDescription>
    <NDC11Code>71205-0488-60</NDC11Code>
    <ProductNDC>71205-488</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101020</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078925</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of.  Hypertension (1.1): 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
    <Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-488-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (76420-488-60) </PackageDescription>
    <NDC11Code>76420-0488-60</NDC11Code>
    <ProductNDC>76420-488</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen 500 Mg</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>ASCLEMED USA INC.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251014</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache. muscular aches. backache. minor pain of arthritis. the common cold. toothache. premenstrual and menstrual cramps.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0003-0524-11</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0003-0524-11)  / 60 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>00003-0524-11</NDC11Code>
    <ProductNDC>0003-0524</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sprycel</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060627</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021986</ApplicationNumber>
    <LabelerName>E.R. Squibb &amp; Sons, L.L.C.</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SPRYCEL (dasatinib) is indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. , 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>SPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. SPRYCEL tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0003-0527-11</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0003-0527-11)  / 60 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>00003-0527-11</NDC11Code>
    <ProductNDC>0003-0527</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sprycel</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060627</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021986</ApplicationNumber>
    <LabelerName>E.R. Squibb &amp; Sons, L.L.C.</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SPRYCEL (dasatinib) is indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. , 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>SPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. SPRYCEL tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0003-0528-11</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0003-0528-11)  / 60 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>00003-0528-11</NDC11Code>
    <ProductNDC>0003-0528</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sprycel</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060627</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021986</ApplicationNumber>
    <LabelerName>E.R. Squibb &amp; Sons, L.L.C.</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SPRYCEL (dasatinib) is indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. , 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>SPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. SPRYCEL tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0168-0410-60</NDCCode>
    <PackageDescription>60 g in 1 TUBE (0168-0410-60) </PackageDescription>
    <NDC11Code>00168-0410-60</NDC11Code>
    <ProductNDC>0168-0410</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednicarbate</ProprietaryName>
    <NonProprietaryName>Prednicarbate</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20070309</StartMarketingDate>
    <EndMarketingDate>20241231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077236</ApplicationNumber>
    <LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PREDNICARBATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20070309</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednicarbate ointment 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Prednicarbate ointment 0.1% contains the non-halogenated prednisolone derivative prednicarbate. The topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Each gram of prednicarbate ointment 0.1% contains 1.0 mg of prednicarbate USP in a base consisting of white petrolatum, glyceryl monooleate, octyldodecanol NF, and propylene glycol. Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. The CAS Registry Number is 73771-04-7. The chemical structure is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0480-5101-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0480-5101-06) </PackageDescription>
    <NDC11Code>00480-5101-06</NDC11Code>
    <ProductNDC>0480-5101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211094</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0480-5102-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0480-5102-06) </PackageDescription>
    <NDC11Code>00480-5102-06</NDC11Code>
    <ProductNDC>0480-5102</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211094</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>0480-5103-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0480-5103-06) </PackageDescription>
    <NDC11Code>00480-5103-06</NDC11Code>
    <ProductNDC>0480-5103</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250918</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211094</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-721-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-721-06) </PackageDescription>
    <NDC11Code>16571-0721-06</NDC11Code>
    <ProductNDC>16571-721</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091388</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-­piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water.Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets.Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-599-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-599-60) </PackageDescription>
    <NDC11Code>43598-0599-60</NDC11Code>
    <ProductNDC>43598-599</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250303</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213383</ApplicationNumber>
    <LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with.  newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.  chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.  Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
    <Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S  C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide &amp; N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-600-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-600-60) </PackageDescription>
    <NDC11Code>43598-0600-60</NDC11Code>
    <ProductNDC>43598-600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250303</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213383</ApplicationNumber>
    <LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with.  newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.  chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.  Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
    <Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S  C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide &amp; N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-601-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-601-60) </PackageDescription>
    <NDC11Code>43598-0601-60</NDC11Code>
    <ProductNDC>43598-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250303</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213383</ApplicationNumber>
    <LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with.  newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.  chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.  Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
    <Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S  C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide &amp; N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-684-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (46708-684-60) </PackageDescription>
    <NDC11Code>46708-0684-60</NDC11Code>
    <ProductNDC>46708-684</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216261</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablet is indicated for the treatment of adult patients with : 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>Dasatinib tablet is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6- methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5- thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is off-white to yellowish powder. The drug substance is practically insoluble in water and slightly to very slightly soluble in methanol and freely soluble in dimethyl sulfoxide, soluble in N,N-dimethyl formamide. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-685-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (46708-685-60) </PackageDescription>
    <NDC11Code>46708-0685-60</NDC11Code>
    <ProductNDC>46708-685</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216261</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablet is indicated for the treatment of adult patients with : 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>Dasatinib tablet is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6- methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5- thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is off-white to yellowish powder. The drug substance is practically insoluble in water and slightly to very slightly soluble in methanol and freely soluble in dimethyl sulfoxide, soluble in N,N-dimethyl formamide. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-686-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (46708-686-60) </PackageDescription>
    <NDC11Code>46708-0686-60</NDC11Code>
    <ProductNDC>46708-686</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216261</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dasatinib tablet is indicated for the treatment of adult patients with : 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>Dasatinib tablet is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6- methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5- thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is off-white to yellowish powder. The drug substance is practically insoluble in water and slightly to very slightly soluble in methanol and freely soluble in dimethyl sulfoxide, soluble in N,N-dimethyl formamide. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-5451-0</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5451-0) </PackageDescription>
    <NDC11Code>50090-5451-00</NDC11Code>
    <ProductNDC>50090-5451</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207655</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f]  [1,4] thiazepin-11-yl-1­-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water. Quetiapine extended-release tablets USP are supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film-coated. Inactive ingredients for quetiapine extended-release tablets USP are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, sodium citrate, titanium dioxide. In addition, the 50 mg contains iron oxide red and iron oxide yellow, the 200 mg, and 300 mg contains iron oxide yellow.Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. USP dissolution test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-5759-0</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (54868-5759-0)  &gt; 60 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>54868-5759-00</NDC11Code>
    <ProductNDC>54868-5759</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sprycel</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070212</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021986</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>SPRYCEL® (dasatinib) is indicated for the treatment of adults with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of SPRYCEL is based on cytogenetic response and major molecular response rates [see Clinical Studies (14.1)]. The trial is ongoing and further data will be required to determine long-term outcome. , 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. , 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
    <Description>SPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S  H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. SPRYCEL tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>60505-3628-6</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (60505-3628-6) </PackageDescription>
    <NDC11Code>60505-3628-06</NDC11Code>
    <ProductNDC>60505-3628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dasatinib</ProprietaryName>
    <NonProprietaryName>Dasatinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240903</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202103</ApplicationNumber>
    <LabelerName>Apotex Corp.</LabelerName>
    <SubstanceName>DASATINIB</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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