RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>33261-361-23</NDCCode>
    <PackageDescription>23 CAPSULE in 1 BOTTLE (33261-361-23)</PackageDescription>
    <NDC11Code>33261-0361-23</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>21130-361-23</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-361-23)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0361-23</NDC11Code>
    <ProductNDC>21130-361</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079205</ApplicationNumber>
    <LabelerName>BETTER LIVING BRANDS, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: 1 headache, 2 toothache, 3 backache, 4 menstrual cramps, 5 the common cold, 6 muscular aches, 7 minor pain of arthritis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33261-366-23</NDCCode>
    <PackageDescription>23 CAPSULE in 1 BOTTLE (33261-366-23)</PackageDescription>
    <NDC11Code>33261-0366-23</NDC11Code>
    <ProductNDC>33261-366</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040875</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-408-23</NDCCode>
    <PackageDescription>23 CAPSULE in 1 BOTTLE (33261-408-23)</PackageDescription>
    <NDC11Code>33261-0408-23</NDC11Code>
    <ProductNDC>33261-408</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040887</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride USP has the chemical name of α, α -Dimethylphenethylamine hydrochloride. The structural formula is as follows: 1    .</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-471-23</NDCCode>
    <PackageDescription>23 TABLET in 1 BOTTLE (33261-471-23)</PackageDescription>
    <NDC11Code>33261-0471-23</NDC11Code>
    <ProductNDC>33261-471</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040876</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride USP has the chemical name of α, α -Dimethylphenethylamine hydrochloride. The structural formula is as follows: 1    .</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-07</NDCCode>
    <PackageDescription>7 CAPSULE in 1 BOTTLE (33261-361-07)</PackageDescription>
    <NDC11Code>33261-0361-07</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-08</NDCCode>
    <PackageDescription>8 CAPSULE in 1 BOTTLE (33261-361-08)</PackageDescription>
    <NDC11Code>33261-0361-08</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (33261-361-14)</PackageDescription>
    <NDC11Code>33261-0361-14</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-15</NDCCode>
    <PackageDescription>15 CAPSULE in 1 BOTTLE (33261-361-15)</PackageDescription>
    <NDC11Code>33261-0361-15</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (33261-361-28)</PackageDescription>
    <NDC11Code>33261-0361-28</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (33261-361-30)</PackageDescription>
    <NDC11Code>33261-0361-30</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-40</NDCCode>
    <PackageDescription>40 CAPSULE in 1 BOTTLE (33261-361-40)</PackageDescription>
    <NDC11Code>33261-0361-40</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-45</NDCCode>
    <PackageDescription>45 CAPSULE in 1 BOTTLE (33261-361-45)</PackageDescription>
    <NDC11Code>33261-0361-45</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-361-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (33261-361-60)</PackageDescription>
    <NDC11Code>33261-0361-60</NDC11Code>
    <ProductNDC>33261-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040886</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride has the chemical name of α, α, -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Red #3, FD&amp;C Red #40, titanium dioxide and the 30 mg capsules contain D&amp;C Yellow #10, FD&amp;C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&amp;C blue #1/Brilliant blue FCF aluminum lake, D&amp;C red #28 and gelatin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-737-01</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (33261-737-01)  &gt; 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>33261-0737-01</NDC11Code>
    <ProductNDC>33261-737</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ofloxacin</ProprietaryName>
    <NonProprietaryName>Ofloxacin</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20080317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076128</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>OFLOXACIN</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus.Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus.Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.</IndicationAndUsage>
    <Description>Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is. Ofloxacin otic solution contains 0.3% (3mg/mL) ofloxacin with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and purified water, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0468-56</NDCCode>
    <PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56) </PackageDescription>
    <NDC11Code>00069-0468-56</NDC11Code>
    <ProductNDC>0069-0468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chantix</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060510</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021928</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CHANTIX is indicated for use as an aid to smoking-cessation treatment.</IndicationAndUsage>
    <Description>CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 ∙ C4H6O6. The chemical structure is. CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0469-28</NDCCode>
    <PackageDescription>56 TABLET, FILM COATED in 1 BLISTER PACK (0069-0469-28) </PackageDescription>
    <NDC11Code>00069-0469-28</NDC11Code>
    <ProductNDC>0069-0469</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chantix</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060510</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021928</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250922</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CHANTIX is indicated for use as an aid to smoking-cessation treatment.</IndicationAndUsage>
    <Description>CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 ∙ C4H6O6. The chemical structure is. CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0469-56</NDCCode>
    <PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (0069-0469-56) </PackageDescription>
    <NDC11Code>00069-0469-56</NDC11Code>
    <ProductNDC>0069-0469</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chantix</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060510</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021928</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060510</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CHANTIX is indicated for use as an aid to smoking-cessation treatment.</IndicationAndUsage>
    <Description>CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 ∙ C4H6O6. The chemical structure is. CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0471-28</NDCCode>
    <PackageDescription>1 KIT in 1 BLISTER PACK (0069-0471-28)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00069-0471-28</NDC11Code>
    <ProductNDC>0069-0471</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chantix</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20060510</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021928</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250922</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CHANTIX is indicated for use as an aid to smoking-cessation treatment.</IndicationAndUsage>
    <Description>CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 ∙ C4H6O6. The chemical structure is. CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-5091-85</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0378-5091-85)  *  11 TABLET, FILM COATED in 1 BLISTER PACK (0378-5089-46)  *  42 TABLET, FILM COATED in 1 BLISTER PACK (0378-5090-23) </PackageDescription>
    <NDC11Code>00378-5091-85</NDC11Code>
    <ProductNDC>0378-5091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline</ProprietaryName>
    <NonProprietaryName>Varenicline</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240314</StartMarketingDate>
    <EndMarketingDate>20260430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202019</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240314</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is an off-white to brown colored powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h](3)benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg capsule shaped, white, film-coated tablet debossed with M on one side and VT 0.5 on the other side and a 1 mg capsule-shaped, white, film-coated tablet debossed with M on one side and VT 1.0 on the other side. Each 0.5 mg varenicline tablet contains 0.855 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.710 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, croscarmellose sodium, glyceryl dibehenate, hypromellose, mannitol, polyethylene glycol, titanium dioxide and triacetin. The 1 mg varenicline tablet contains 10 mg of phosphorus.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-361-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (13668-361-01) </PackageDescription>
    <NDC11Code>13668-0361-01</NDC11Code>
    <ProductNDC>13668-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250519</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206942</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are 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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and 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 USP, along with corn starch, pregelatinized starch (corn) and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (In 75, 100, 200, 225 and 300mg) contain red iron oxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-361-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (13668-361-05) </PackageDescription>
    <NDC11Code>13668-0361-05</NDC11Code>
    <ProductNDC>13668-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250519</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206942</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are 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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and 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 USP, along with corn starch, pregelatinized starch (corn) and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (In 75, 100, 200, 225 and 300mg) contain red iron oxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-361-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (13668-361-30) </PackageDescription>
    <NDC11Code>13668-0361-30</NDC11Code>
    <ProductNDC>13668-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250519</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206942</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are 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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and 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 USP, along with corn starch, pregelatinized starch (corn) and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (In 75, 100, 200, 225 and 300mg) contain red iron oxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-361-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (13668-361-60) </PackageDescription>
    <NDC11Code>13668-0361-60</NDC11Code>
    <ProductNDC>13668-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250519</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206942</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are 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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and 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 USP, along with corn starch, pregelatinized starch (corn) and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (In 75, 100, 200, 225 and 300mg) contain red iron oxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>14141-361-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (14141-361-01)  / 27 g in 1 TUBE</PackageDescription>
    <NDC11Code>14141-0361-01</NDC11Code>
    <ProductNDC>14141-361</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cyzone Studio Look Matte Finish Base De Alta Cobertura Y Larga Duracion Fps 20 Medio 350n</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241125</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>BEL STAR S A</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>40; 23.5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ayuda a prevenir quemaduras solares.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>14789-104-05</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (14789-104-05)  / 10 mL in 1 VIAL, MULTI-DOSE (14789-104-07) </PackageDescription>
    <NDC11Code>14789-0104-05</NDC11Code>
    <ProductNDC>14789-104</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Succinylcholine Chloride</ProprietaryName>
    <NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20210111</StartMarketingDate>
    <EndMarketingDate>20240721</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213552</ApplicationNumber>
    <LabelerName>Nexus Pharmaceuticals Inc</LabelerName>
    <SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210111</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240721</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
    <Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as an ultra-short-acting, depolarizing, skeletal muscle relaxant. See HOW SUPPLIED for a summary of content and characteristics of the solution. The solution is for intramuscular (IM) or intravenous (IV) use. Succinylcholine Chloride is chemically designated as Ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl) bis(oxy)] bis [N, N, N-trimethyl-, dichloride, its molecular formula is C14H30Cl2N2O4, and its molecular weight is 361.31. It has the following structural formula:. Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. Succinylcholine Chloride, USP is a white, odorless, crystalline powder. It is freely soluble in water, slightly soluble in alcohol, and practically insoluble in ether. The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated. Solution intended for multiple-dose administration contains methylparaben 0.18% and propylparaben 0.02%, as preservatives. Product not requiring dilution (multiple-dose fliptop vial) contains sodium chloride to render isotonic. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 3.6 (3.0 to 4.5). See table in HOW SUPPLIED for characteristics. Sodium Chloride, USP, chemically designated NaCl, is a white crystalline compound freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>47993-361-01</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE (47993-361-01) </PackageDescription>
    <NDC11Code>47993-0361-01</NDC11Code>
    <ProductNDC>47993-361</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanizizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M</ApplicationNumber>
    <LabelerName>NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>g/112mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses：. For hand sanitizing to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50090-5670-0</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (50090-5670-0)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>50090-5670-00</NDC11Code>
    <ProductNDC>50090-5670</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ofloxacin</ProprietaryName>
    <NonProprietaryName>Ofloxacin Otic</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20200317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211525</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OFLOXACIN</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ofloxacin otic solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa Staphylococcus aureus, and Streptococcus pneumoniae.</IndicationAndUsage>
    <Description>Ofloxacin otic solution, 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The molecular formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.37. The structural formula is. Ofloxacin, USP is white to off-white or pale yellow crystalline powder. It is soluble in glacial acetic acid; sparingly soluble in chloroform and in 0.1N sodium hydroxide; sparingly soluble to slightly soluble in methylene chloride; slightly soluble in dimethylformamide and very slightly soluble in methyl alcohol and water. Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH between 6.0 and 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7996-0</NDCCode>
    <PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (50090-7996-0) </PackageDescription>
    <NDC11Code>50090-7996-00</NDC11Code>
    <ProductNDC>50090-7996</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219106</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260617</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine,(2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg (white to off-white, capsule shaped film coated tablets, debossed with “1 C” on one side and plain on other side.) and 1 mg (light blue, capsule shaped film-coated tablets, debossed with “2 C” on one side and plain on other side.) Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: silicified microcrystalline cellulose, maltodextrin, croscarmellose sodium, stearic acid, hypromellose, titanium dioxide, macrogol/polyethylene glycol, triacetin. In addition to these, the 1 mg tablet film coating includes FD&amp;C blue #2/indigo carmine aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7997-0</NDCCode>
    <PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (50090-7997-0) </PackageDescription>
    <NDC11Code>50090-7997-00</NDC11Code>
    <ProductNDC>50090-7997</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline</ProprietaryName>
    <NonProprietaryName>Varenicline</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211862</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260617</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to light brown color powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano 6H-pyrazino[2,3 h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3  C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: 0.5 mg white to off white, round, biconvex-coated tablets, debossed with "T" on one side and "2" on the other side  and 1 mg yellow, round, biconvex-coated tablets, debossed with "T" on one side and "1" on the other side. Each 0.5 mg varenicline tablet contains 0.855 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.710 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, talc and titanium dioxide. The 1 mg tablet also contains iron oxide yellow.</Description>
  </NDC>
</NDCList>