RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>82619-124-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-124-02) </PackageDescription>
    <NDC11Code>82619-0124-02</NDC11Code>
    <ProductNDC>82619-124</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-124-01</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (82619-124-01) </PackageDescription>
    <NDC11Code>82619-0124-01</NDC11Code>
    <ProductNDC>82619-124</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-105-02</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (82619-105-02) </PackageDescription>
    <NDC11Code>82619-0105-02</NDC11Code>
    <ProductNDC>82619-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol</ProprietaryName>
    <NonProprietaryName>Haloperidol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218162</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HALOPERIDOL</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
    <Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula.                                         C 21H 23ClFNO 2375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose 102, hypromellose E3 Premium LV, sodium starch glycolate type A, colloidal silicon dioxide, and magnesium stearate. In addition, the 1 mg and 2 mg tablets also contain D&amp;C Yellow # 10 Aluminum Lake and 5 mg, 10 mg and 20 mg tablets also contain Lake Pigment HT 6027 D&amp;C Red#27/Phloxine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-106-02</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (82619-106-02) </PackageDescription>
    <NDC11Code>82619-0106-02</NDC11Code>
    <ProductNDC>82619-106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol</ProprietaryName>
    <NonProprietaryName>Haloperidol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218162</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HALOPERIDOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
    <Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula.                                         C 21H 23ClFNO 2375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose 102, hypromellose E3 Premium LV, sodium starch glycolate type A, colloidal silicon dioxide, and magnesium stearate. In addition, the 1 mg and 2 mg tablets also contain D&amp;C Yellow # 10 Aluminum Lake and 5 mg, 10 mg and 20 mg tablets also contain Lake Pigment HT 6027 D&amp;C Red#27/Phloxine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-107-02</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (82619-107-02) </PackageDescription>
    <NDC11Code>82619-0107-02</NDC11Code>
    <ProductNDC>82619-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol</ProprietaryName>
    <NonProprietaryName>Haloperidol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218162</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HALOPERIDOL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
    <Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula.                                         C 21H 23ClFNO 2375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose 102, hypromellose E3 Premium LV, sodium starch glycolate type A, colloidal silicon dioxide, and magnesium stearate. In addition, the 1 mg and 2 mg tablets also contain D&amp;C Yellow # 10 Aluminum Lake and 5 mg, 10 mg and 20 mg tablets also contain Lake Pigment HT 6027 D&amp;C Red#27/Phloxine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-108-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (82619-108-02) </PackageDescription>
    <NDC11Code>82619-0108-02</NDC11Code>
    <ProductNDC>82619-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol</ProprietaryName>
    <NonProprietaryName>Haloperidol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218162</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HALOPERIDOL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
    <Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula.                                         C 21H 23ClFNO 2375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose 102, hypromellose E3 Premium LV, sodium starch glycolate type A, colloidal silicon dioxide, and magnesium stearate. In addition, the 1 mg and 2 mg tablets also contain D&amp;C Yellow # 10 Aluminum Lake and 5 mg, 10 mg and 20 mg tablets also contain Lake Pigment HT 6027 D&amp;C Red#27/Phloxine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-109-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (82619-109-02) </PackageDescription>
    <NDC11Code>82619-0109-02</NDC11Code>
    <ProductNDC>82619-109</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol</ProprietaryName>
    <NonProprietaryName>Haloperidol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218162</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HALOPERIDOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
    <Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula.                                         C 21H 23ClFNO 2375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose 102, hypromellose E3 Premium LV, sodium starch glycolate type A, colloidal silicon dioxide, and magnesium stearate. In addition, the 1 mg and 2 mg tablets also contain D&amp;C Yellow # 10 Aluminum Lake and 5 mg, 10 mg and 20 mg tablets also contain Lake Pigment HT 6027 D&amp;C Red#27/Phloxine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-110-02</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (82619-110-02) </PackageDescription>
    <NDC11Code>82619-0110-02</NDC11Code>
    <ProductNDC>82619-110</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Haloperidol</ProprietaryName>
    <NonProprietaryName>Haloperidol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218162</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HALOPERIDOL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
    <Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula.                                         C 21H 23ClFNO 2375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose 102, hypromellose E3 Premium LV, sodium starch glycolate type A, colloidal silicon dioxide, and magnesium stearate. In addition, the 1 mg and 2 mg tablets also contain D&amp;C Yellow # 10 Aluminum Lake and 5 mg, 10 mg and 20 mg tablets also contain Lake Pigment HT 6027 D&amp;C Red#27/Phloxine Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-111-02</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (82619-111-02) </PackageDescription>
    <NDC11Code>82619-0111-02</NDC11Code>
    <ProductNDC>82619-111</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202047</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks., 2 Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . , 3 Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets, USP contains rizatriptan benzoate, a selective 5- hydroxytryptamine 1B/1D(5-HT 1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: 1H-indole-3-ethanamine, N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-,monobenzoateand its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a White to almost white crystalline powder that is soluble in water; sparingly soluble in alcohol, slightly soluble in methylene chloride. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.530 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: Lactose Monohydrate USP NF, Microcrystalline Cellulose USP NF, Pregelatinised Starch USP NF, Ferric Oxide USP NF and Magnesium Stearate USP NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-112-02</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (82619-112-02) </PackageDescription>
    <NDC11Code>82619-0112-02</NDC11Code>
    <ProductNDC>82619-112</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121231</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202047</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks., 2 Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . , 3 Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets, USP contains rizatriptan benzoate, a selective 5- hydroxytryptamine 1B/1D(5-HT 1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: 1H-indole-3-ethanamine, N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-,monobenzoateand its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a White to almost white crystalline powder that is soluble in water; sparingly soluble in alcohol, slightly soluble in methylene chloride. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.530 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: Lactose Monohydrate USP NF, Microcrystalline Cellulose USP NF, Pregelatinised Starch USP NF, Ferric Oxide USP NF and Magnesium Stearate USP NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-114-02</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (82619-114-02) </PackageDescription>
    <NDC11Code>82619-0114-02</NDC11Code>
    <ProductNDC>82619-114</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Silodosin</ProprietaryName>
    <NonProprietaryName>Silodosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213230</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>SILODOSIN</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Silodosin, a selective alpha‑1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)] . Silodosin capsules is not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Silodosin capsules, USP is a selective antagonist of alpha‑1 adrenoreceptors. The chemical name of silodosin, USP is 1‑(3‑Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.53. The structural formula of silodosin is:. Silodosin, USP is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is freely soluble in acetic acid, and in absolute alcohol, and insoluble in water. Each Silodosin capsule, USP  8 mg for oral administration contains 8 mg silodosin, USP, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with black ink containing shellac, propylene glycol, ammonia solution- concentrated, black iron oxide and potassium hydroxide. Each Silodosin capsule, USP  4 mg for oral administration contains 4 mg silodosin, USP, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with black ink Containing shellac, propylene glycol, ammonia solution-concentrated, black iron oxide and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-115-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-115-02) </PackageDescription>
    <NDC11Code>82619-0115-02</NDC11Code>
    <ProductNDC>82619-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218875</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
    <Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride and its molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride, USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules are for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for atomoxetine capsules USP, 10 mg contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 18 mg contain titanium dioxide, gelatin, iron oxide yellow and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contain titanium dioxide, gelatin, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 60 mg contain titanium dioxide, gelatin, iron oxide yellow, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contain titanium dioxide, gelatin, iron oxide red, and sodium lauryl sulfate. The imprinting ink for atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg have the following components: black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-116-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-116-02) </PackageDescription>
    <NDC11Code>82619-0116-02</NDC11Code>
    <ProductNDC>82619-116</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218875</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>18</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
    <Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride and its molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride, USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules are for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for atomoxetine capsules USP, 10 mg contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 18 mg contain titanium dioxide, gelatin, iron oxide yellow and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contain titanium dioxide, gelatin, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 60 mg contain titanium dioxide, gelatin, iron oxide yellow, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contain titanium dioxide, gelatin, iron oxide red, and sodium lauryl sulfate. The imprinting ink for atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg have the following components: black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-117-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-117-02) </PackageDescription>
    <NDC11Code>82619-0117-02</NDC11Code>
    <ProductNDC>82619-117</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218875</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
    <Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride and its molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride, USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules are for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for atomoxetine capsules USP, 10 mg contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 18 mg contain titanium dioxide, gelatin, iron oxide yellow and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contain titanium dioxide, gelatin, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 60 mg contain titanium dioxide, gelatin, iron oxide yellow, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contain titanium dioxide, gelatin, iron oxide red, and sodium lauryl sulfate. The imprinting ink for atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg have the following components: black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-118-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-118-02) </PackageDescription>
    <NDC11Code>82619-0118-02</NDC11Code>
    <ProductNDC>82619-118</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218875</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
    <Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride and its molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride, USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules are for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for atomoxetine capsules USP, 10 mg contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 18 mg contain titanium dioxide, gelatin, iron oxide yellow and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contain titanium dioxide, gelatin, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 60 mg contain titanium dioxide, gelatin, iron oxide yellow, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contain titanium dioxide, gelatin, iron oxide red, and sodium lauryl sulfate. The imprinting ink for atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg have the following components: black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-119-02</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (82619-119-02) </PackageDescription>
    <NDC11Code>82619-0119-02</NDC11Code>
    <ProductNDC>82619-119</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218875</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
    <Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride and its molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride, USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules are for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for atomoxetine capsules USP, 10 mg contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 18 mg contain titanium dioxide, gelatin, iron oxide yellow and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contain titanium dioxide, gelatin, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 60 mg contain titanium dioxide, gelatin, iron oxide yellow, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contain titanium dioxide, gelatin, iron oxide red, and sodium lauryl sulfate. The imprinting ink for atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg have the following components: black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-120-02</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (82619-120-02) </PackageDescription>
    <NDC11Code>82619-0120-02</NDC11Code>
    <ProductNDC>82619-120</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218875</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
    <Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride and its molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride, USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules are for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for atomoxetine capsules USP, 10 mg contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 18 mg contain titanium dioxide, gelatin, iron oxide yellow and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contain titanium dioxide, gelatin, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 60 mg contain titanium dioxide, gelatin, iron oxide yellow, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contain titanium dioxide, gelatin, iron oxide red, and sodium lauryl sulfate. The imprinting ink for atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg have the following components: black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-121-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-121-02) </PackageDescription>
    <NDC11Code>82619-0121-02</NDC11Code>
    <ProductNDC>82619-121</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atomoxetine</ProprietaryName>
    <NonProprietaryName>Atomoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218875</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
    <Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride and its molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride, USP is a white to practically white solid, which is sparingly soluble in water. Atomoxetine capsules are for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for atomoxetine capsules USP, 10 mg contain gelatin, titanium dioxide and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 18 mg contain titanium dioxide, gelatin, iron oxide yellow and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contain titanium dioxide, gelatin, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 60 mg contain titanium dioxide, gelatin, iron oxide yellow, FD &amp; C Blue No. 2 and sodium lauryl sulfate. The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contain titanium dioxide, gelatin, iron oxide red, and sodium lauryl sulfate. The imprinting ink for atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg have the following components: black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-122-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-122-02) </PackageDescription>
    <NDC11Code>82619-0122-02</NDC11Code>
    <ProductNDC>82619-122</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-123-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-123-02) </PackageDescription>
    <NDC11Code>82619-0123-02</NDC11Code>
    <ProductNDC>82619-123</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-125-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-125-02) </PackageDescription>
    <NDC11Code>82619-0125-02</NDC11Code>
    <ProductNDC>82619-125</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-126-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-126-02) </PackageDescription>
    <NDC11Code>82619-0126-02</NDC11Code>
    <ProductNDC>82619-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-127-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-127-02) </PackageDescription>
    <NDC11Code>82619-0127-02</NDC11Code>
    <ProductNDC>82619-127</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-128-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-128-02) </PackageDescription>
    <NDC11Code>82619-0128-02</NDC11Code>
    <ProductNDC>82619-128</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>225</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-129-02</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (82619-129-02) </PackageDescription>
    <NDC11Code>82619-0129-02</NDC11Code>
    <ProductNDC>82619-129</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213423</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240920</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
    <Description>Pregabalin USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-131-02</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (82619-131-02) </PackageDescription>
    <NDC11Code>82619-0131-02</NDC11Code>
    <ProductNDC>82619-131</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
    <NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250508</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040150</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250508</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale,and  Plasmodium vivax in adult and pediatric patients. ( 1.1) , 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1) , 3 Treatment of rheumatoid arthritis in adults. ( 1.2) , 4 Treatment of systemic lupus erythematosus in adults. ( 1.3) , 5 Treatment of chronic discoid lupus erythematosus in adults. ( 1.4) .</IndicationAndUsage>
    <Description>Hydroxychloroquine sulfate tablets, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate, USP is a white or practically white crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform and ether. Hydroxychloroquine sulfate tablets, USP 200 mg for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: corn starch, pregelatinized starch, anhydrous dibasic calcium phosphate, magnesium stearate, hypromellose 2910(3 mPas), hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, hypromellose 2910(50 mPas).</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-132-02</NDCCode>
    <PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82619-132-02) </PackageDescription>
    <NDC11Code>82619-0132-02</NDC11Code>
    <ProductNDC>82619-132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260829</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219460</ApplicationNumber>
    <LabelerName>Creekwood Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260829</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension. Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine. Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Hypertrophic Subaortic Stenosis. Propranolol hydrochloride extended-release capsules improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.</IndicationAndUsage>
    <Description>Propranolol hydrochloride extended-release capsules (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl) amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C 16H 21NO 2· HCl. Propranolol hydrochloride USP is a white to almost white crystalline powder which is soluble in water and 96% ethanol, slightly soluble in chloroform and practically insoluble in ethyl ether and heptane. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules USP is formulated to provide a sustained release of propranolol hydrochloride USP. Propranolol hydrochloride extended-release capsules USP is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
  </NDC>
  <NDC>
    <NDCCode>82619-133-02</NDCCode>
    <PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82619-133-02) </PackageDescription>
    <NDC11Code>82619-0133-02</NDC11Code>
    <ProductNDC>82619-133</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
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    <Description>Propranolol hydrochloride extended-release capsules (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl) amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C 16H 21NO 2· HCl. Propranolol hydrochloride USP is a white to almost white crystalline powder which is soluble in water and 96% ethanol, slightly soluble in chloroform and practically insoluble in ethyl ether and heptane. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules USP is formulated to provide a sustained release of propranolol hydrochloride USP. Propranolol hydrochloride extended-release capsules USP is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
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    <Description>Propranolol hydrochloride extended-release capsules (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl) amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C 16H 21NO 2· HCl. Propranolol hydrochloride USP is a white to almost white crystalline powder which is soluble in water and 96% ethanol, slightly soluble in chloroform and practically insoluble in ethyl ether and heptane. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules USP is formulated to provide a sustained release of propranolol hydrochloride USP. Propranolol hydrochloride extended-release capsules USP is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
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    <IndicationAndUsage>Hypertension. Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine. Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Hypertrophic Subaortic Stenosis. Propranolol hydrochloride extended-release capsules improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.</IndicationAndUsage>
    <Description>Propranolol hydrochloride extended-release capsules (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl) amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C 16H 21NO 2· HCl. Propranolol hydrochloride USP is a white to almost white crystalline powder which is soluble in water and 96% ethanol, slightly soluble in chloroform and practically insoluble in ethyl ether and heptane. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules USP is formulated to provide a sustained release of propranolol hydrochloride USP. Propranolol hydrochloride extended-release capsules USP is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
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