RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>68001-658-52</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (68001-658-52)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>68001-0658-52</NDC11Code>
    <ProductNDC>68001-658</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211180</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate release oral haloperidol product.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:. The molecular formula is C 31H 41CIFNO 3and has a molecular weight of 530.12. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol decanoate injection, 50 mg/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate, USP 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of Haloperidol decanoate injection, 100 mg/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate, USP 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>51655-658-52</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (51655-658-52) </PackageDescription>
    <NDC11Code>51655-0658-52</NDC11Code>
    <ProductNDC>51655-658</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210126</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205253</ApplicationNumber>
    <LabelerName>Northwind Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1).</IndicationAndUsage>
    <Description>Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist.  Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]- 1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride. It is a white to off-white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows. Molecular Formula:C 19H 22C lN 5OHCl. Molecular Weight:408.33. Each trazodone hydrochloride tablet, USP for oral administration contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. The USP Dissolution Test is pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-658-41</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (68001-658-41)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>68001-0658-41</NDC11Code>
    <ProductNDC>68001-658</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211180</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate release oral haloperidol product.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:. The molecular formula is C 31H 41CIFNO 3and has a molecular weight of 530.12. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol decanoate injection, 50 mg/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate, USP 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of Haloperidol decanoate injection, 100 mg/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate, USP 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-658-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (16714-658-01) </PackageDescription>
    <NDC11Code>16714-0658-01</NDC11Code>
    <ProductNDC>16714-658</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170126</StartMarketingDate>
    <EndMarketingDate>20240930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078627</ApplicationNumber>
    <LabelerName>Northstar Rx LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170126</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-156-00</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (68001-156-00) </PackageDescription>
    <NDC11Code>68001-0156-00</NDC11Code>
    <ProductNDC>68001-156</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077653</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below.                                                       Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-157-00</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (68001-157-00) </PackageDescription>
    <NDC11Code>68001-0157-00</NDC11Code>
    <ProductNDC>68001-157</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077653</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below.                                                       Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-158-00</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (68001-158-00) </PackageDescription>
    <NDC11Code>68001-0158-00</NDC11Code>
    <ProductNDC>68001-158</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077653</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below.                                                       Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-159-00</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (68001-159-00) </PackageDescription>
    <NDC11Code>68001-0159-00</NDC11Code>
    <ProductNDC>68001-159</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077653</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below.                                                       Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-160-00</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (68001-160-00) </PackageDescription>
    <NDC11Code>68001-0160-00</NDC11Code>
    <ProductNDC>68001-160</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077653</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below.                                                       Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-323-31</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (68001-323-31)  &gt; 20 mL in 1 VIAL, GLASS (68001-323-29) </PackageDescription>
    <NDC11Code>68001-0323-31</NDC11Code>
    <ProductNDC>68001-323</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205883</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3) .</IndicationAndUsage>
    <Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6- [(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem, USP is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem, USP is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem, USP and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem, USP and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration (2.4)].</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-324-57</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (68001-324-57)  &gt; 30 mL in 1 VIAL, GLASS (68001-324-58) </PackageDescription>
    <NDC11Code>68001-0324-57</NDC11Code>
    <ProductNDC>68001-324</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205883</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/30mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3) .</IndicationAndUsage>
    <Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6- [(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem, USP is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem, USP is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem, USP and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem, USP and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration (2.4)].</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-446-31</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (68001-446-31)  &gt; 20 mL in 1 VIAL (68001-446-29) </PackageDescription>
    <NDC11Code>68001-0446-31</NDC11Code>
    <ProductNDC>68001-446</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200831</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206086</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200831</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (   1.3)   .</IndicationAndUsage>
    <Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxilic acid trihydrate. Its empirical formula is C 17H 25N 3O 5S∙3H 2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram meropenem for injection vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq)  [see   Dosage and Administration (2.4)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-447-57</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (68001-447-57)  &gt; 30 mL in 1 VIAL (68001-447-58) </PackageDescription>
    <NDC11Code>68001-0447-57</NDC11Code>
    <ProductNDC>68001-447</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meropenem</ProprietaryName>
    <NonProprietaryName>Meropenem</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20200831</StartMarketingDate>
    <EndMarketingDate>20230930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206086</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>MEROPENEM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/30mL</StrengthUnit>
    <Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200831</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meropenem for injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1) , 2 Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older only). (   1.3)   .</IndicationAndUsage>
    <Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxilic acid trihydrate. Its empirical formula is C 17H 25N 3O 5S∙3H 2O with a molecular weight of 437.52. Its structural formula is:. Meropenem for injection is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram meropenem for injection vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq)  [see   Dosage and Administration (2.4)] .</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-578-48</NDCCode>
    <PackageDescription>3 AMPULE in 1 CARTON (68001-578-48)  / 1 mL in 1 AMPULE (68001-578-59) </PackageDescription>
    <NDC11Code>68001-0578-48</NDC11Code>
    <ProductNDC>68001-578</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209101</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol, USP. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, USP, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of haloperidol decanoate 50 mg (base)/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of haloperidol decanoate 100 mg (base)/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-579-48</NDCCode>
    <PackageDescription>5 AMPULE in 1 CARTON (68001-579-48)  / 1 mL in 1 AMPULE (68001-579-59) </PackageDescription>
    <NDC11Code>68001-0579-48</NDC11Code>
    <ProductNDC>68001-579</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209101</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol, USP. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, USP, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of haloperidol decanoate 50 mg (base)/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of haloperidol decanoate 100 mg (base)/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-580-41</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (68001-580-41)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>68001-0580-41</NDC11Code>
    <ProductNDC>68001-580</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209101</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol, USP. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, USP, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of haloperidol decanoate 50 mg (base)/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of haloperidol decanoate 100 mg (base)/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-581-41</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (68001-581-41)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>68001-0581-41</NDC11Code>
    <ProductNDC>68001-581</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209101</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol, USP. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, USP, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of haloperidol decanoate 50 mg (base)/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of haloperidol decanoate 100 mg (base)/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-581-48</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (68001-581-48)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>68001-0581-48</NDC11Code>
    <ProductNDC>68001-581</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209101</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol, USP. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, USP, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of haloperidol decanoate 50 mg (base)/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of haloperidol decanoate 100 mg (base)/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-581-82</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (68001-581-82)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>68001-0581-82</NDC11Code>
    <ProductNDC>68001-581</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209101</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol, USP. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, USP, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of haloperidol decanoate 50 mg (base)/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of haloperidol decanoate 100 mg (base)/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-582-41</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (68001-582-41)  / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>68001-0582-41</NDC11Code>
    <ProductNDC>68001-582</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230811</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209101</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol, USP. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, USP, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of haloperidol decanoate 50 mg (base)/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of haloperidol decanoate 100 mg (base)/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-598-06</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-598-06) </PackageDescription>
    <NDC11Code>68001-0598-06</NDC11Code>
    <ProductNDC>68001-598</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215478</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is 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 C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline 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 lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose and magnesium stearate. The film coating for all quetiapine extended-release tablets USP contains hypromellose, polyethylene glycol and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.57 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.52 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Meets USP Dissolution Test 12.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-599-06</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-599-06) </PackageDescription>
    <NDC11Code>68001-0599-06</NDC11Code>
    <ProductNDC>68001-599</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215478</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is 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 C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline 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 lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose and magnesium stearate. The film coating for all quetiapine extended-release tablets USP contains hypromellose, polyethylene glycol and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.57 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.52 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Meets USP Dissolution Test 12.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-600-06</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-600-06) </PackageDescription>
    <NDC11Code>68001-0600-06</NDC11Code>
    <ProductNDC>68001-600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215478</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is 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 C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline 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 lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose and magnesium stearate. The film coating for all quetiapine extended-release tablets USP contains hypromellose, polyethylene glycol and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.57 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.52 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Meets USP Dissolution Test 12.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-601-06</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-601-06) </PackageDescription>
    <NDC11Code>68001-0601-06</NDC11Code>
    <ProductNDC>68001-601</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215478</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is 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 C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline 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 lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose and magnesium stearate. The film coating for all quetiapine extended-release tablets USP contains hypromellose, polyethylene glycol and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.57 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.52 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Meets USP Dissolution Test 12.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-602-06</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-602-06) </PackageDescription>
    <NDC11Code>68001-0602-06</NDC11Code>
    <ProductNDC>68001-602</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215478</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine is 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 C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline 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 lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose and magnesium stearate. The film coating for all quetiapine extended-release tablets USP contains hypromellose, polyethylene glycol and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.57 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.52 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Meets USP Dissolution Test 12.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-657-51</NDCCode>
    <PackageDescription>3 VIAL, SINGLE-DOSE in 1 CARTON (68001-657-51)  / 1 mL in 1 VIAL, SINGLE-DOSE (68001-657-41) </PackageDescription>
    <NDC11Code>68001-0657-51</NDC11Code>
    <ProductNDC>68001-657</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211180</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate release oral haloperidol product.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:. The molecular formula is C 31H 41CIFNO 3and has a molecular weight of 530.12. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol decanoate injection, 50 mg/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate, USP 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of Haloperidol decanoate injection, 100 mg/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate, USP 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-657-56</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (68001-657-56)  / 1 mL in 1 VIAL, SINGLE-DOSE (68001-657-41) </PackageDescription>
    <NDC11Code>68001-0657-56</NDC11Code>
    <ProductNDC>68001-657</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211180</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate release oral haloperidol product.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:. The molecular formula is C 31H 41CIFNO 3and has a molecular weight of 530.12. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol decanoate injection, 50 mg/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate, USP 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of Haloperidol decanoate injection, 100 mg/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate, USP 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68001-659-41</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (68001-659-41)  / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>68001-0659-41</NDC11Code>
    <ProductNDC>68001-659</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol Decanoate</ProprietaryName>
    <NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211180</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol decanoate is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate release oral haloperidol product.</IndicationAndUsage>
    <Description>Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:. The molecular formula is C 31H 41CIFNO 3and has a molecular weight of 530.12. Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol decanoate injection, 50 mg/mL for IM injection contains 50 mg haloperidol (present as haloperidol decanoate, USP 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative. Each mL of Haloperidol decanoate injection, 100 mg/mL for IM injection contains 100 mg haloperidol (present as haloperidol decanoate, USP 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>10135-658-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10135-658-60) </PackageDescription>
    <NDC11Code>10135-0658-60</NDC11Code>
    <ProductNDC>10135-658</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine</ProprietaryName>
    <ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
    <NonProprietaryName>Quetiapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209635</ApplicationNumber>
    <LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicate d for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic or mixed episode s (1.2), 3 Bipolar disorder, depressive episode s (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
    <Description>Quetiapine extended-release tablets are 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 crystalline powder which is soluble in 0.1N hydrochloric acid, slightly soluble in water, in alcohol, and in methanol. Quetiapine extended-release tablets,USP are supplied for oral administration as 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 are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, and magnesium stearate. The film coating for all quetiapine extended-release tablets, USP contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (200 mg and 300 mg tablets) are included in the film coating of specific strengths. Each 150 mg tablet contains 172.7 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.5 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
  </NDC>
  <NDC>
    <NDCCode>10237-658-09</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-658-09)  / 25 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0658-09</NDC11Code>
    <ProductNDC>10237-658</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advance White Extreme Whitening</ProprietaryName>
    <ProprietaryNameSuffix>Tartar Control</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20120129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use aids in the prevention of dental decay.</IndicationAndUsage>
  </NDC>
</NDCList>