RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>69315-185-24</NDCCode>
    <PackageDescription>24 TABLET in 1 BOTTLE (69315-185-24) </PackageDescription>
    <NDC11Code>69315-0185-24</NDC11Code>
    <ProductNDC>69315-185</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213929</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin Calcium Tablets contain either 5 mg, 10 mg, 15 mg or 25 mg leucovorin as the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L- glutamic acid and the inactive ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Pregelatinized Starch. This is equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium. Leucovorin is a water soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only. The structural formula of leucovorin calcium is.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-185-12</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE (69315-185-12) </PackageDescription>
    <NDC11Code>69315-0185-12</NDC11Code>
    <ProductNDC>69315-185</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213929</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin Calcium Tablets contain either 5 mg, 10 mg, 15 mg or 25 mg leucovorin as the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L- glutamic acid and the inactive ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Pregelatinized Starch. This is equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium. Leucovorin is a water soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only. The structural formula of leucovorin calcium is.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-186-24</NDCCode>
    <PackageDescription>24 TABLET in 1 BOTTLE (69315-186-24) </PackageDescription>
    <NDC11Code>69315-0186-24</NDC11Code>
    <ProductNDC>69315-186</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213929</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin Calcium Tablets contain either 5 mg, 10 mg, 15 mg or 25 mg leucovorin as the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L- glutamic acid and the inactive ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Pregelatinized Starch. This is equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium. Leucovorin is a water soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only. The structural formula of leucovorin calcium is.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-501-24</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOTTLE (69315-501-24)  &gt; 240 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>69315-0501-24</NDC11Code>
    <ProductNDC>69315-501</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203967</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-02</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>69315-503-24</NDCCode>
    <PackageDescription>236.5 mL in 1 BOTTLE (69315-503-24) </PackageDescription>
    <NDC11Code>69315-0503-24</NDC11Code>
    <ProductNDC>69315-503</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aminocaproic Acid</ProprietaryName>
    <NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214140</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>AMINOCAPROIC ACID</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>12634-185-74</NDCCode>
    <PackageDescription>24 CAPSULE in 1 BOTTLE (12634-185-74)</PackageDescription>
    <NDC11Code>12634-0185-74</NDC11Code>
    <ProductNDC>12634-185</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065271</ApplicationNumber>
    <LabelerName>Apotheca Inc.</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract.  (1.1 – 1.4), 2 In combination for treatment of  H. pylori infection and duodenal ulcer disease.  (1.5).</IndicationAndUsage>
    <Description>Formulation of amoxicillin capsules, USP contains amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>50844-185-08</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50844-185-08)  &gt; 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>50844-0185-08</NDC11Code>
    <ProductNDC>50844-185</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Childrens Chewable Pain Reliever</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900410</StartMarketingDate>
    <EndMarketingDate>20200829</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>L.N.K. International, Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19900410</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200829</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>53329-185-58</NDCCode>
    <PackageDescription>24 APPLICATOR in 1 PACKAGE (53329-185-58)  / 9.2 mL in 1 APPLICATOR</PackageDescription>
    <NDC11Code>53329-0185-58</NDC11Code>
    <ProductNDC>53329-185</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medline</ProprietaryName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231001</StartMarketingDate>
    <EndMarketingDate>20251031</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Medline Industries, LP</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>32</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20231001</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55319-185-24</NDCCode>
    <PackageDescription>24 TABLET in 1 BOTTLE (55319-185-24) </PackageDescription>
    <NDC11Code>55319-0185-24</NDC11Code>
    <ProductNDC>55319-185</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211544</ApplicationNumber>
    <LabelerName>FAMILY DOLLAR</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ premenstrual and menstrual cramps ■ the common cold ■ headache. ■ toothache ■ temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>56136-185-01</NDCCode>
    <PackageDescription>24 PATCH in 1 PACKAGE (56136-185-01)  / .0227 g in 1 PATCH</PackageDescription>
    <NDC11Code>56136-0185-01</NDC11Code>
    <ProductNDC>56136-185</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Blemish Control Dots</ProprietaryName>
    <ProprietaryNameSuffix>Aloe Vera</ProprietaryNameSuffix>
    <NonProprietaryName>Salicylic Acid 0.5%</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240320</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>Ganzhou Olivee Cosmetic Co., Ltd.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-03-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>soothe and helps diminish the redness and irritation of blemished skin and absorbs excess oil for faster healing.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83602-185-24</NDCCode>
    <PackageDescription>24 BAG in 1 BOX (83602-185-24)  / 1 PATCH in 1 BAG / 21 g in 1 PATCH</PackageDescription>
    <NDC11Code>83602-0185-24</NDC11Code>
    <ProductNDC>83602-185</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Pain Relief Gel -patch</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260228</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Guangzhou Liuquanmiao Import &amp; Export Trade Co., Ltd.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69315-136-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (69315-136-01) </PackageDescription>
    <NDC11Code>69315-0136-01</NDC11Code>
    <ProductNDC>69315-136</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090168</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
    <Description>Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-136-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (69315-136-10) </PackageDescription>
    <NDC11Code>69315-0136-10</NDC11Code>
    <ProductNDC>69315-136</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090168</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
    <Description>Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-137-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (69315-137-01) </PackageDescription>
    <NDC11Code>69315-0137-01</NDC11Code>
    <ProductNDC>69315-137</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090168</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
    <Description>Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-137-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (69315-137-10) </PackageDescription>
    <NDC11Code>69315-0137-10</NDC11Code>
    <ProductNDC>69315-137</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090168</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
    <Description>Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-138-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (69315-138-01) </PackageDescription>
    <NDC11Code>69315-0138-01</NDC11Code>
    <ProductNDC>69315-138</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090168</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
    <Description>Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-138-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (69315-138-10) </PackageDescription>
    <NDC11Code>69315-0138-10</NDC11Code>
    <ProductNDC>69315-138</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benztropine Mesylate</ProprietaryName>
    <NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090168</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-11-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
    <Description>Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C21H25NOCH4O3S, and its structural formula is. Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-226-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-226-01) </PackageDescription>
    <NDC11Code>69315-0226-01</NDC11Code>
    <ProductNDC>69315-226</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Theophylline</ProprietaryName>
    <NonProprietaryName>Theophylline</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214950</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>THEOPHYLLINE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.</IndicationAndUsage>
    <Description>Theophylline is structurally classified as a methylxanthine. It occurs as a white, practically odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1,3-Dimethyl-3,7-dihydro-1H-purine-2,6-dione, and is represented by the following structural formula. This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each theophylline extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Theophylline extended-release tablets also contain as inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-227-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-227-01) </PackageDescription>
    <NDC11Code>69315-0227-01</NDC11Code>
    <ProductNDC>69315-227</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Theophylline</ProprietaryName>
    <NonProprietaryName>Theophylline</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214950</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>THEOPHYLLINE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.</IndicationAndUsage>
    <Description>Theophylline is structurally classified as a methylxanthine. It occurs as a white, practically odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1,3-Dimethyl-3,7-dihydro-1H-purine-2,6-dione, and is represented by the following structural formula. This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each theophylline extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Theophylline extended-release tablets also contain as inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-275-20</NDCCode>
    <PackageDescription>120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69315-275-20) </PackageDescription>
    <NDC11Code>69315-0275-20</NDC11Code>
    <ProductNDC>69315-275</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Potassium</ProprietaryName>
    <NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220324</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA022202</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diclofenac Potassium is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
    <Description>Diclofenac Potassium Capsule is a nonsteroidal anti-inflammatory drug, available as liquid-filled capsules of 25 mg for oral administration. Diclofenac potassium is a white to slight yellowish crystalline powder. It is sparingly soluble in water at 25ºC. The chemical name is benzeneacetic acid, 2-[(2,6-dichlorophenyl) amino]-, monopotassium salt. The molecular weight is 334.24. Its molecular formula is C14H10Cl2NKO2, and it has the following chemical structure. The inactive ingredients in Diclofenac Potassiuminclude: ProSorb® (a proprietary combination of polyethylene glycol 400, glycerin, sorbitol, povidone, polysorbate 80, and hydrochloric acid), isopropyl alcohol, and mineral oil. The capsule shells contain gelatin, sorbitol, isopropyl alcohol, glycerin, and mineral oil.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-330-05</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (69315-330-05)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>69315-0330-05</NDC11Code>
    <ProductNDC>69315-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate/timolol Maleate Ophthalmic Solution</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate And Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219093</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE; TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.</IndicationAndUsage>
    <Description>Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent). The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt. In solution, Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a pale yellow colored powder to wheatish colored powder and is soluble in water and practically insoluble in anhydrous ethanol and in toluene. Timolol maleate appears as a white or almost white, crystalline powder and is soluble in water; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Each mL of brimonidine tartrate/timolol maleate ophthalmic solution contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-330-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (69315-330-10)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>69315-0330-10</NDC11Code>
    <ProductNDC>69315-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate/timolol Maleate Ophthalmic Solution</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate And Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219093</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE; TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.</IndicationAndUsage>
    <Description>Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent). The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt. In solution, Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a pale yellow colored powder to wheatish colored powder and is soluble in water and practically insoluble in anhydrous ethanol and in toluene. Timolol maleate appears as a white or almost white, crystalline powder and is soluble in water; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Each mL of brimonidine tartrate/timolol maleate ophthalmic solution contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>69315-330-15</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (69315-330-15)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>69315-0330-15</NDC11Code>
    <ProductNDC>69315-330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate/timolol Maleate Ophthalmic Solution</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate And Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219093</ApplicationNumber>
    <LabelerName>Leading Pharma, LLC</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE; TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.</IndicationAndUsage>
    <Description>Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent). The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt. In solution, Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a pale yellow colored powder to wheatish colored powder and is soluble in water and practically insoluble in anhydrous ethanol and in toluene. Timolol maleate appears as a white or almost white, crystalline powder and is soluble in water; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Each mL of brimonidine tartrate/timolol maleate ophthalmic solution contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-0597-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0527-0597-01) </PackageDescription>
    <NDC11Code>00527-0597-01</NDC11Code>
    <ProductNDC>0527-0597</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087022</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N  HCl    M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose,  polyethylene glycol, titanium dioxide,  FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-0597-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (0527-0597-10) </PackageDescription>
    <NDC11Code>00527-0597-10</NDC11Code>
    <ProductNDC>0527-0597</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087022</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N  HCl    M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose,  polyethylene glycol, titanium dioxide,  FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-1308-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0527-1308-01) </PackageDescription>
    <NDC11Code>00527-1308-01</NDC11Code>
    <ProductNDC>0527-1308</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087022</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N  HCl    M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose,  polyethylene glycol, titanium dioxide,  FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-1308-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (0527-1308-10) </PackageDescription>
    <NDC11Code>00527-1308-10</NDC11Code>
    <ProductNDC>0527-1308</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087022</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N  HCl    M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose,  polyethylene glycol, titanium dioxide,  FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-1310-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0527-1310-01) </PackageDescription>
    <NDC11Code>00527-1310-01</NDC11Code>
    <ProductNDC>0527-1310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087022</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N  HCl    M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose,  polyethylene glycol, titanium dioxide,  FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-1310-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (0527-1310-10) </PackageDescription>
    <NDC11Code>00527-1310-10</NDC11Code>
    <ProductNDC>0527-1310</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087022</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N  HCl    M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose,  polyethylene glycol, titanium dioxide,  FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-1438-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0527-1438-01) </PackageDescription>
    <NDC11Code>00527-1438-01</NDC11Code>
    <ProductNDC>0527-1438</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091359</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N  HCl    M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 40, FD&amp;C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&amp;C Red # 28, and FD&amp;C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&amp;C Yellow # 10, FD&amp;C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&amp;C Yellow # 6, FD&amp;C Blue # 1, and FD&amp;C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose,  polyethylene glycol, titanium dioxide,  FD&amp;C Blue No. 1 Aluminum Lake, polysorbate 80, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Yellow No. 6 Aluminum Lake, gelatin, FD&amp;C Blue No. 1 and D&amp;C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&amp;C Blue # 2 Aluminum Lake, FD&amp;C Red # 40 Aluminum Lake, FD&amp;C Blue # 1 Aluminum Lake, and D&amp;C Yellow # 10 Aluminum Lake.</Description>
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