RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>55289-701-32</NDCCode>
    <PackageDescription>32 TABLET in 1 BOTTLE, PLASTIC (55289-701-32) </PackageDescription>
    <NDC11Code>55289-0701-32</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>65649-701-32</NDCCode>
    <PackageDescription>32 TABLET in 1 BOTTLE, PLASTIC (65649-701-32)</PackageDescription>
    <NDC11Code>65649-0701-32</NDC11Code>
    <ProductNDC>65649-701</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Osmoprep</ProprietaryName>
    <NonProprietaryName>Sodium Phosphate, Monobasic, Monohydrate, Sodium Phosphate, Dibasic Anhydrous</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060515</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021892</ApplicationNumber>
    <LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS</SubstanceName>
    <StrengthNumber>1.102; .398</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-21</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>74638-701-32</NDCCode>
    <PackageDescription>909 mL in 1 BOTTLE (74638-701-32) </PackageDescription>
    <NDC11Code>74638-0701-32</NDC11Code>
    <ProductNDC>74638-701</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nurses Station Hand Sanitizer Gel With Aloe 70% Alcohol</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Jet Foods LC d/b/a Nurse's Station LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>79363-701-32</NDCCode>
    <PackageDescription>946 mL in 1 BOTTLE (79363-701-32) </PackageDescription>
    <NDC11Code>79363-0701-32</NDC11Code>
    <ProductNDC>79363-701</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>REALCHEM MANUFACTURING</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>79685-701-32</NDCCode>
    <PackageDescription>950 mL in 1 BOTTLE (79685-701-32) </PackageDescription>
    <NDC11Code>79685-0701-32</NDC11Code>
    <ProductNDC>79685-701</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Handstand</ProprietaryName>
    <ProprietaryNameSuffix>Hand Sanitizer</ProprietaryNameSuffix>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200730</StartMarketingDate>
    <EndMarketingDate>20231223</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Creative Chemicals, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231223</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55289-701-07</NDCCode>
    <PackageDescription>7 TABLET in 1 BOTTLE, PLASTIC (55289-701-07) </PackageDescription>
    <NDC11Code>55289-0701-07</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (55289-701-14) </PackageDescription>
    <NDC11Code>55289-0701-14</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (55289-701-15) </PackageDescription>
    <NDC11Code>55289-0701-15</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE, PLASTIC (55289-701-21) </PackageDescription>
    <NDC11Code>55289-0701-21</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-28</NDCCode>
    <PackageDescription>28 TABLET in 1 BOTTLE, PLASTIC (55289-701-28) </PackageDescription>
    <NDC11Code>55289-0701-28</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (55289-701-30) </PackageDescription>
    <NDC11Code>55289-0701-30</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-42</NDCCode>
    <PackageDescription>42 TABLET in 1 BOTTLE, PLASTIC (55289-701-42) </PackageDescription>
    <NDC11Code>55289-0701-42</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-45</NDCCode>
    <PackageDescription>45 TABLET in 1 BOTTLE, PLASTIC (55289-701-45) </PackageDescription>
    <NDC11Code>55289-0701-45</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-56</NDCCode>
    <PackageDescription>56 TABLET in 1 BOTTLE, PLASTIC (55289-701-56) </PackageDescription>
    <NDC11Code>55289-0701-56</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161024</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (55289-701-60) </PackageDescription>
    <NDC11Code>55289-0701-60</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (55289-701-90) </PackageDescription>
    <NDC11Code>55289-0701-90</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-701-98</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (55289-701-98) </PackageDescription>
    <NDC11Code>55289-0701-98</NDC11Code>
    <ProductNDC>55289-701</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>PD-Rx Pharmaceuticals, Inc.</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>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in 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 is a sympathomimetic amine anorectic. Its chemical name is 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&amp;C Red #33, FD&amp;C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-701-00</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (21695-701-00)</PackageDescription>
    <NDC11Code>21695-0701-00</NDC11Code>
    <ProductNDC>21695-701</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19971229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074650</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>200; 40</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Sulfamethoxazole and Trimethoprim Oral Suspension USP is a synthetic antibacterial combination product. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound. It has the following structural formula is. C10H11N3O3S M.W. 253.28. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound. It has the following structural formula is. C14H18N4O3 M.W. 290.32. Each teaspoonful (5 mL) for oral administration, contains 200 mg sulfamethoxazole and 40 mg trimethoprim in a vehicle containing alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&amp;C Red No. 40, FD&amp;C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&amp;C Red No. 40, FD&amp;C Yellow No. 6 and artificial cherry flavor.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-701-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (21695-701-16)</PackageDescription>
    <NDC11Code>21695-0701-16</NDC11Code>
    <ProductNDC>21695-701</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19971229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074650</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>200; 40</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Sulfamethoxazole and Trimethoprim Oral Suspension USP is a synthetic antibacterial combination product. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound. It has the following structural formula is. C10H11N3O3S M.W. 253.28. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound. It has the following structural formula is. C14H18N4O3 M.W. 290.32. Each teaspoonful (5 mL) for oral administration, contains 200 mg sulfamethoxazole and 40 mg trimethoprim in a vehicle containing alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&amp;C Red No. 40, FD&amp;C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&amp;C Red No. 40, FD&amp;C Yellow No. 6 and artificial cherry flavor.</Description>
  </NDC>
  <NDC>
    <NDCCode>49483-701-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (49483-701-01) </PackageDescription>
    <NDC11Code>49483-0701-01</NDC11Code>
    <ProductNDC>49483-701</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075465</ApplicationNumber>
    <LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&amp;C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>49483-701-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (49483-701-10) </PackageDescription>
    <NDC11Code>49483-0701-10</NDC11Code>
    <ProductNDC>49483-701</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075465</ApplicationNumber>
    <LabelerName>TIME CAP LABORATORIES, INC.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2)].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3)].  Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N- methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol), 20 mg (64.7 µmol), or 40 mg (129.3 µmol) of fluoxetine and the following inactive ingredients: pregelatinized starch. The capsule shells and imprinting ink contain FD&amp;C Blue- 1 (brilliant blue FCF), gelatin, titanium dioxide, sodium lauryl sulfate, shellac, povidone, sodium hydroxide, black iron oxide and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>75854-701-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (75854-701-01) </PackageDescription>
    <NDC11Code>75854-0701-01</NDC11Code>
    <ProductNDC>75854-701</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dhivy</ProprietaryName>
    <NonProprietaryName>Carbidopa Levodopa</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220713</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214869</ApplicationNumber>
    <LabelerName>Avion Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>CARBIDOPA HYDRATE; LEVODOPA</SubstanceName>
    <StrengthNumber>25; 100</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DHIVY is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
    <Description>DHIVY®(carbidopa levodopa) is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in tablets for oral use. Carbidopa is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (–)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxy-benzene) propanoic acid monohydrate. It has a pKa of 2.3. Its molecular formula is C10H14N2O4H2O and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (–)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. It has a pKa of 2.32. Its molecular formula is C9H11NO4 and its structural formula is:. DHIVY is supplied as tablets for oral administration containing 25 mg of carbidopa and 100 mg of levodopa. The inactive ingredients are magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-337-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (55289-337-01) </PackageDescription>
    <NDC11Code>55289-0337-01</NDC11Code>
    <ProductNDC>55289-337</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital</ProprietaryName>
    <NonProprietaryName>Phenobarbital</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030201</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PHENOBARBITAL</SubstanceName>
    <StrengthNumber>32.4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-08-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55289-535-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (55289-535-30) </PackageDescription>
    <NDC11Code>55289-0535-30</NDC11Code>
    <ProductNDC>55289-535</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital</ProprietaryName>
    <NonProprietaryName>Phenobarbital</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030201</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PHENOBARBITAL</SubstanceName>
    <StrengthNumber>32.4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55289-592-10</NDCCode>
    <PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-10) </PackageDescription>
    <NDC11Code>55289-0592-10</NDC11Code>
    <ProductNDC>55289-592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicloxacillin Sodium</ProprietaryName>
    <NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062286</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DICLOXACILLIN SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility  Testing) . Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.</IndicationAndUsage>
    <Description>Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase resistant, acid resistant semisynthetic penicillin suitable for oral administration. It is monosodium (2 S,5 R,6 R)-6-[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate, and has following structural formula:. C 19H 16Cl 2N 3NaO 5 S·H 2O MW 510.32. Each capsule for oral administration contains dicloxacillin sodium, USP equivalent to 250 mg or 500 mg of dicloxacillin. The inactive ingredient is Magnesium Stearate. The capsule shells and print constituents contains D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, FD&amp;C Blue #1, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake, D&amp;C Yellow #10, Gelatin, Shellac, Sodium Lauryl Sulfate, Sorbitan Monolaurate, Black Iron Oxide, Titanium Dioxide, Propylene Glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-592-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-20) </PackageDescription>
    <NDC11Code>55289-0592-20</NDC11Code>
    <ProductNDC>55289-592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicloxacillin Sodium</ProprietaryName>
    <NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062286</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DICLOXACILLIN SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility  Testing) . Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.</IndicationAndUsage>
    <Description>Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase resistant, acid resistant semisynthetic penicillin suitable for oral administration. It is monosodium (2 S,5 R,6 R)-6-[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate, and has following structural formula:. C 19H 16Cl 2N 3NaO 5 S·H 2O MW 510.32. Each capsule for oral administration contains dicloxacillin sodium, USP equivalent to 250 mg or 500 mg of dicloxacillin. The inactive ingredient is Magnesium Stearate. The capsule shells and print constituents contains D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, FD&amp;C Blue #1, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake, D&amp;C Yellow #10, Gelatin, Shellac, Sodium Lauryl Sulfate, Sorbitan Monolaurate, Black Iron Oxide, Titanium Dioxide, Propylene Glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-592-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-28) </PackageDescription>
    <NDC11Code>55289-0592-28</NDC11Code>
    <ProductNDC>55289-592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicloxacillin Sodium</ProprietaryName>
    <NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062286</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DICLOXACILLIN SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility  Testing) . Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.</IndicationAndUsage>
    <Description>Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase resistant, acid resistant semisynthetic penicillin suitable for oral administration. It is monosodium (2 S,5 R,6 R)-6-[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate, and has following structural formula:. C 19H 16Cl 2N 3NaO 5 S·H 2O MW 510.32. Each capsule for oral administration contains dicloxacillin sodium, USP equivalent to 250 mg or 500 mg of dicloxacillin. The inactive ingredient is Magnesium Stearate. The capsule shells and print constituents contains D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, FD&amp;C Blue #1, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake, D&amp;C Yellow #10, Gelatin, Shellac, Sodium Lauryl Sulfate, Sorbitan Monolaurate, Black Iron Oxide, Titanium Dioxide, Propylene Glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-592-40</NDCCode>
    <PackageDescription>40 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-40) </PackageDescription>
    <NDC11Code>55289-0592-40</NDC11Code>
    <ProductNDC>55289-592</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicloxacillin Sodium</ProprietaryName>
    <NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062286</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DICLOXACILLIN SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility  Testing) . Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.</IndicationAndUsage>
    <Description>Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase resistant, acid resistant semisynthetic penicillin suitable for oral administration. It is monosodium (2 S,5 R,6 R)-6-[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate, and has following structural formula:. C 19H 16Cl 2N 3NaO 5 S·H 2O MW 510.32. Each capsule for oral administration contains dicloxacillin sodium, USP equivalent to 250 mg or 500 mg of dicloxacillin. The inactive ingredient is Magnesium Stearate. The capsule shells and print constituents contains D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Blue #1 Aluminum Lake, FD&amp;C Blue #1, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake, D&amp;C Yellow #10, Gelatin, Shellac, Sodium Lauryl Sulfate, Sorbitan Monolaurate, Black Iron Oxide, Titanium Dioxide, Propylene Glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0869-0816-35</NDCCode>
    <PackageDescription>701 mL in 1 BOTTLE, PLASTIC (0869-0816-35) </PackageDescription>
    <NDC11Code>00869-0816-35</NDC11Code>
    <ProductNDC>0869-0816</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dandruff</ProprietaryName>
    <NonProprietaryName>Selenium Sulfide</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160925</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>Vi-Jon, LLC</LabelerName>
    <SubstanceName>SELENIUM SULFIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160925</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent recurrence of itching, irritation, redness, flaking and scaling associated with dandruff and seborrheic dermatitis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10056-701-34</NDCCode>
    <PackageDescription>170 g in 1 BOTTLE, PLASTIC (10056-701-34)</PackageDescription>
    <NDC11Code>10056-0701-34</NDC11Code>
    <ProductNDC>10056-701</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Peter Island Continuous Sport Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
    <NonProprietaryName>Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130627</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Access Business Group LLC</LabelerName>
    <SubstanceName>HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>15; 6; 3; 5; 2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>