RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>70015-675-40</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (70015-675-40)  &gt; 113 g in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>70015-0675-40</NDC11Code>
    <ProductNDC>70015-675</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instaflex Pain Relief</ProprietaryName>
    <NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191211</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>50; 100</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 sprains, 5 bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42255-603-01</NDCCode>
    <PackageDescription>40 POUCH in 1 PACKAGE (42255-603-01)  &gt; .675 g in 1 POUCH</PackageDescription>
    <NDC11Code>42255-0603-01</NDC11Code>
    <ProductNDC>42255-603</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acne Wipes</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>SWAB</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150506</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>ZHEJIANG GREENFACE HOUSEWARES CO., LTD.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For  the treatment oa acne.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43063-675-40</NDCCode>
    <PackageDescription>40 CAPSULE in 1 BOTTLE, PLASTIC (43063-675-40) </PackageDescription>
    <NDC11Code>43063-0675-40</NDC11Code>
    <ProductNDC>43063-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName>
    <NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100927</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016620</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>NITROFURANTOIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-08-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160621</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0115-9927-10</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9927-10) </PackageDescription>
    <NDC11Code>00115-9927-10</NDC11Code>
    <ProductNDC>0115-9927</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19760802</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA017078</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19760802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextroamphetamine sulfate is indicated in. Narcolepsy. Attention Deficit Disorder with Hyperactivity. As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine sulfate is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.</IndicationAndUsage>
    <Description>Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. Structural formula. Each extended-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with brown cap and natural body, contains 5 mg, 10 mg or 15 mg dextroamphetamine sulfate. The 5 mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10 mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15 mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&amp;C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-9928-10</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9928-10) </PackageDescription>
    <NDC11Code>00115-9928-10</NDC11Code>
    <ProductNDC>0115-9928</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19760802</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA017078</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19760802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextroamphetamine sulfate is indicated in. Narcolepsy. Attention Deficit Disorder with Hyperactivity. As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine sulfate is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.</IndicationAndUsage>
    <Description>Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. Structural formula. Each extended-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with brown cap and natural body, contains 5 mg, 10 mg or 15 mg dextroamphetamine sulfate. The 5 mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10 mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15 mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&amp;C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-9929-10</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9929-10) </PackageDescription>
    <NDC11Code>00115-9929-10</NDC11Code>
    <ProductNDC>0115-9929</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
    <ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19760802</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA017078</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19760802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dextroamphetamine sulfate is indicated in. Narcolepsy. Attention Deficit Disorder with Hyperactivity. As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program. Dextroamphetamine sulfate is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.</IndicationAndUsage>
    <Description>Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. Structural formula. Each extended-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with brown cap and natural body, contains 5 mg, 10 mg or 15 mg dextroamphetamine sulfate. The 5 mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10 mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15 mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&amp;C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>14539-675-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 CONTAINER (14539-675-01) </PackageDescription>
    <NDC11Code>14539-0675-01</NDC11Code>
    <ProductNDC>14539-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201507</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190423</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine pamoate is a light yellow odorless powder, practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4 -methylenebis[3-hydroxy-2-naphthoate] (1:1) and can be structurally represented as follows. Chemical Formula: C21H27ClN2O2.C23H16O6. Molecular Weight: 763.29. Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin, titanium dioxide, FD&amp;C Blue #1, FD&amp;C Red #40, D&amp;C Yellow #10), printing ink which contains shellac glaze ~45% (20% esterified) in Ethanol, iron oxide black, n-butyl alcohol, isopropyl alcohol, propylene glycol and ammonium hydroxide 28%); magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>14539-675-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 CONTAINER (14539-675-05) </PackageDescription>
    <NDC11Code>14539-0675-05</NDC11Code>
    <ProductNDC>14539-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201507</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190423</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine pamoate is a light yellow odorless powder, practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4 -methylenebis[3-hydroxy-2-naphthoate] (1:1) and can be structurally represented as follows. Chemical Formula: C21H27ClN2O2.C23H16O6. Molecular Weight: 763.29. Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin, titanium dioxide, FD&amp;C Blue #1, FD&amp;C Red #40, D&amp;C Yellow #10), printing ink which contains shellac glaze ~45% (20% esterified) in Ethanol, iron oxide black, n-butyl alcohol, isopropyl alcohol, propylene glycol and ammonium hydroxide 28%); magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>16571-675-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (16571-675-16) </PackageDescription>
    <NDC11Code>16571-0675-16</NDC11Code>
    <ProductNDC>16571-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital</ProprietaryName>
    <NonProprietaryName>Phenobarbital</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>PHENOBARBITAL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2020-09-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A. Sedative. B. Anticonvulsant- For the treatment of generalized and partial seizures.</IndicationAndUsage>
    <Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In sub hypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in either, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C12H12N2O3. Its molecular weight is 232.24. It has the following structural formula. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 13.5%. The oral solution also contains Glycerin, Sucrose, FD&amp;C Red #40, Orange Flavor and Purified Water.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-675-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (21695-675-30)</PackageDescription>
    <NDC11Code>21695-0675-30</NDC11Code>
    <ProductNDC>21695-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Warfarin Sodium</ProprietaryName>
    <NonProprietaryName>Warfarin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060530</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040663</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>WARFARIN SODIUM</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin sodium tablets are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
    <Description>Warfarin sodium tablet (crystalline warfarin sodium) is an anticoagulant, which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its molecular formula is C19H15NaO4, and its structural formula may be represented by the following. Crystalline warfarin sodium occurs as a white crystalline powder, odorless or practically odorless. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and pregelatinized starch. Additionally each 1 mg tablet contains D&amp;C red no. 6 barium lake, 2 mg tablet contains FD&amp;C blue no. 2 aluminum lake and FD&amp;C red no. 40 aluminum lake, 2.5 mg tablet contains D&amp;C yellow no. 10 aluminum lake and FD&amp;C blue no. 1 aluminum lake, 3 mg tablet contains FD&amp;C yellow no. 6 aluminum lake, FD&amp;C blue no. 2 aluminum lake and FD&amp;C red no. 40 aluminum lake, 4 mg tablet contains FD&amp;C blue no. 1 aluminum lake, 5 mg tablet contains FD&amp;C yellow no. 6 aluminum lake, 6 mg tablet contains FD&amp;C yellow no. 6 aluminum lake and FD&amp;C blue no. 1 aluminum lake, 7.5 mg tablet contains D&amp;C yellow no. 10 aluminum lake and FD&amp;C yellow no.6 aluminum lake and 10 mg tablet is dye free.</Description>
  </NDC>
  <NDC>
    <NDCCode>51655-675-52</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, DISPENSING (51655-675-52)</PackageDescription>
    <NDC11Code>51655-0675-52</NDC11Code>
    <ProductNDC>51655-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Terazosin</ProprietaryName>
    <NonProprietaryName>Terazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075317</ApplicationNumber>
    <LabelerName>Northwind Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name,molecular formula. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Each capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochlolde. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains black iron oxide; the 2 mg capsule shell also contains D&amp;C Yellow #10; the 5 mg capsule shell also contains D&amp;C Yellow #10, FD&amp;C Red #40 and D&amp;C Red #28; the 10 mg capsule shell also contains FD&amp;C Green #3 and D&amp;C Yellow#10.</Description>
  </NDC>
  <NDC>
    <NDCCode>64896-673-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (64896-673-10)  / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>64896-0673-10</NDC11Code>
    <ProductNDC>64896-673</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexedrine</ProprietaryName>
    <ProprietaryNameSuffix>Spansule</ProprietaryNameSuffix>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19760802</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017078</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19760802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DEXEDRINE is indicated in. Narcolepsy. Attention Deficit Disorder with Hyperactivity. As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program. DEXEDRINE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms. Limitations of Use. The use of DEXEDRINE is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Precautions, Pediatric Use].</IndicationAndUsage>
    <Description>DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of DEXEDRINE as the neutral sulfate. Structural formula. SPANSULE capsules. Each SPANSULE sustained-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10-mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15-mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&amp;C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>64896-674-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (64896-674-10)  / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>64896-0674-10</NDC11Code>
    <ProductNDC>64896-674</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexedrine</ProprietaryName>
    <ProprietaryNameSuffix>Spansule</ProprietaryNameSuffix>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19760802</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017078</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19760802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DEXEDRINE is indicated in. Narcolepsy. Attention Deficit Disorder with Hyperactivity. As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program. DEXEDRINE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms. Limitations of Use. The use of DEXEDRINE is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Precautions, Pediatric Use].</IndicationAndUsage>
    <Description>DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of DEXEDRINE as the neutral sulfate. Structural formula. SPANSULE capsules. Each SPANSULE sustained-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10-mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15-mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&amp;C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>64896-675-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (64896-675-10)  / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>64896-0675-10</NDC11Code>
    <ProductNDC>64896-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexedrine</ProprietaryName>
    <ProprietaryNameSuffix>Spansule</ProprietaryNameSuffix>
    <NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19760802</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017078</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19760802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>DEXEDRINE is indicated in. Narcolepsy. Attention Deficit Disorder with Hyperactivity. As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program. DEXEDRINE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms. Limitations of Use. The use of DEXEDRINE is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Precautions, Pediatric Use].</IndicationAndUsage>
    <Description>DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of DEXEDRINE as the neutral sulfate. Structural formula. SPANSULE capsules. Each SPANSULE sustained-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10-mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15-mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&amp;C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-675-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-675-01) </PackageDescription>
    <NDC11Code>65862-0675-01</NDC11Code>
    <ProductNDC>65862-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felodipine</ProprietaryName>
    <NonProprietaryName>Felodipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203417</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>FELODIPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C18H19Cl2NO4 and its structural formula is. Felodipine USP is a light yellow to yellow, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture.Felodipine extended-release tablets, USP provide extended release of felodipine USP. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine USP for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: colloidal silicon dioxide, heavy aluminium silicate, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyoxyl 40 hydrogenated castor oil, propyl gallate, sodium stearyl fumarate, titanium dioxide. In addition the 2.5 mg strength contains FD&amp;C blue #2/Indigo carmine aluminum lake and iron oxide yellow and the 5 mg and 10 mg strengths contain iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-675-78</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (65862-675-78)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-675-10) </PackageDescription>
    <NDC11Code>65862-0675-78</NDC11Code>
    <ProductNDC>65862-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felodipine</ProprietaryName>
    <NonProprietaryName>Felodipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203417</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>FELODIPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C18H19Cl2NO4 and its structural formula is. Felodipine USP is a light yellow to yellow, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture.Felodipine extended-release tablets, USP provide extended release of felodipine USP. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine USP for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: colloidal silicon dioxide, heavy aluminium silicate, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyoxyl 40 hydrogenated castor oil, propyl gallate, sodium stearyl fumarate, titanium dioxide. In addition the 2.5 mg strength contains FD&amp;C blue #2/Indigo carmine aluminum lake and iron oxide yellow and the 5 mg and 10 mg strengths contain iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-675-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-675-90) </PackageDescription>
    <NDC11Code>65862-0675-90</NDC11Code>
    <ProductNDC>65862-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felodipine</ProprietaryName>
    <NonProprietaryName>Felodipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203417</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>FELODIPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C18H19Cl2NO4 and its structural formula is. Felodipine USP is a light yellow to yellow, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture.Felodipine extended-release tablets, USP provide extended release of felodipine USP. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine USP for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: colloidal silicon dioxide, heavy aluminium silicate, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyoxyl 40 hydrogenated castor oil, propyl gallate, sodium stearyl fumarate, titanium dioxide. In addition the 2.5 mg strength contains FD&amp;C blue #2/Indigo carmine aluminum lake and iron oxide yellow and the 5 mg and 10 mg strengths contain iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-675-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-675-99) </PackageDescription>
    <NDC11Code>65862-0675-99</NDC11Code>
    <ProductNDC>65862-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felodipine</ProprietaryName>
    <NonProprietaryName>Felodipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203417</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>FELODIPINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.</IndicationAndUsage>
    <Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C18H19Cl2NO4 and its structural formula is. Felodipine USP is a light yellow to yellow, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture.Felodipine extended-release tablets, USP provide extended release of felodipine USP. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine USP for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: colloidal silicon dioxide, heavy aluminium silicate, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyoxyl 40 hydrogenated castor oil, propyl gallate, sodium stearyl fumarate, titanium dioxide. In addition the 2.5 mg strength contains FD&amp;C blue #2/Indigo carmine aluminum lake and iron oxide yellow and the 5 mg and 10 mg strengths contain iron oxide red and iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>67046-675-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-675-30)</PackageDescription>
    <NDC11Code>67046-0675-30</NDC11Code>
    <ProductNDC>67046-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100825</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077837</ApplicationNumber>
    <LabelerName>Contract Pharmacy Services-PA</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hydroxypropyl methylcellulose (hypromellose), lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>68084-675-21</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-675-21)  / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (68084-675-11) </PackageDescription>
    <NDC11Code>68084-0675-21</NDC11Code>
    <ProductNDC>68084-675</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131217</StartMarketingDate>
    <EndMarketingDate>20240430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090694</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20131217</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults .</IndicationAndUsage>
    <Description>Duloxetine delayed-release capsules USP are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to cream colored powder, which is soluble in methanol. Each capsule contains enteric-coated mini tablets comprising of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated mini tablets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonia solution, black iron oxide, croscarmellose sodium, FD &amp; C Blue 2, gelatin, hypromellose, hypromellose phthalate, lactose monohydrate, magnesium stearate, polysorbate 80, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70015-645-02</NDCCode>
    <PackageDescription>57 g in 1 TUBE (70015-645-02)</PackageDescription>
    <NDC11Code>70015-0645-02</NDC11Code>
    <ProductNDC>70015-645</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Oxy Rub Pain Relief</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Healthy Directions</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-10-11</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70015-645-04</NDCCode>
    <PackageDescription>114 g in 1 TUBE (70015-645-04)</PackageDescription>
    <NDC11Code>70015-0645-04</NDC11Code>
    <ProductNDC>70015-645</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Oxy Rub Pain Relief</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Healthy Directions</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-10-11</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70015-650-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70015-650-02)  &gt; 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>70015-0650-02</NDC11Code>
    <ProductNDC>70015-650</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Oxyrub Max Pain Relief</ProprietaryName>
    <ProprietaryNameSuffix>Cream, 2oz</ProprietaryNameSuffix>
    <NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>25; 100</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses. Temporarily relieves minor aches and pains of muscles and joints associated with: : 1 simple backaches , 2 arthritis , 3 strains , 4 sprains , 5 bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70015-655-04</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70015-655-04)  &gt; 114 g in 1 TUBE</PackageDescription>
    <NDC11Code>70015-0655-04</NDC11Code>
    <ProductNDC>70015-655</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Oxyrub Pro Pain Relief</ProprietaryName>
    <ProprietaryNameSuffix>Cream, 4oz</ProprietaryNameSuffix>
    <NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>25; 100</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses. Temporarily relieves minor aches and pains of muscles and joints associated with: : 1 simple backaches , 2 arthritis , 3 strains , 4 sprains , 5 bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70015-660-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70015-660-02)  / 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>70015-0660-02</NDC11Code>
    <ProductNDC>70015-660</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instaflex Extra Strength Pain Relief Cream</ProprietaryName>
    <NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>25; 100</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Temporarily relieves minor aches and pains of muscles. and joints associated with: : 1 simple backache, 2 arthritis , 3 strains , 4 sprains , 5 bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70015-660-04</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70015-660-04)  / 113 g in 1 TUBE</PackageDescription>
    <NDC11Code>70015-0660-04</NDC11Code>
    <ProductNDC>70015-660</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instaflex Extra Strength Pain Relief Cream</ProprietaryName>
    <NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>25; 100</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Temporarily relieves minor aches and pains of muscles. and joints associated with: : 1 simple backache, 2 arthritis , 3 strains , 4 sprains , 5 bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70015-665-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70015-665-01)  / 28 g in 1 TUBE</PackageDescription>
    <NDC11Code>70015-0665-01</NDC11Code>
    <ProductNDC>70015-665</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instaflex Pain Relief Cream</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Temporarily relieves minor aches and pains. of muscles and joints associated with : 1 simple backache, 2 arthritis , 3 strains , 4 sprains , 5 bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70015-665-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70015-665-02)  / 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>70015-0665-02</NDC11Code>
    <ProductNDC>70015-665</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instaflex Pain Relief Cream</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Temporarily relieves minor aches and pains. of muscles and joints associated with : 1 simple backache, 2 arthritis , 3 strains , 4 sprains , 5 bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70015-665-04</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70015-665-04)  / 113 g in 1 TUBE</PackageDescription>
    <NDC11Code>70015-0665-04</NDC11Code>
    <ProductNDC>70015-665</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instaflex Pain Relief Cream</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses Temporarily relieves minor aches and pains. of muscles and joints associated with : 1 simple backache, 2 arthritis , 3 strains , 4 sprains , 5 bruises.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70015-670-25</NDCCode>
    <PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (70015-670-25)  &gt; 71 g in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>70015-0670-25</NDC11Code>
    <ProductNDC>70015-670</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Instaflex Pain Relief Roll-on</ProprietaryName>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191021</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Healthy Directions, LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves minor aches and pains of muscles and joints associated with: 1 arthritis, 2 strains, 3 sprains, 4 bruises.</IndicationAndUsage>
  </NDC>
</NDCList>