RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>71335-0095-6</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71335-0095-6) </PackageDescription>
    <NDC11Code>71335-0095-06</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0555-0095-96</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (0555-0095-96)  &gt; 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00555-0095-96</NDC11Code>
    <ProductNDC>0555-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonazepam</ProprietaryName>
    <NonProprietaryName>Clonazepam</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20050810</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077194</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>CLONAZEPAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11014-0095-1</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (11014-0095-1)  &gt; 5 VIAL in 1 POUCH &gt; 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>11014-0095-01</NDC11Code>
    <ProductNDC>11014-0095</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Budesonide</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <StartMarketingDate>20130402</StartMarketingDate>
    <EndMarketingDate>20180322</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
    <SubstanceName>BUDESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20180322</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>15631-0095-6</NDCCode>
    <PackageDescription>500 PELLET in 1 PACKAGE (15631-0095-6) </PackageDescription>
    <NDC11Code>15631-0095-06</NDC11Code>
    <ProductNDC>15631-0095</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Calcarea Fluorica</ProprietaryName>
    <NonProprietaryName>Calcarea Fluorica</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151002</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>CALCIUM FLUORIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50332-0095-6</NDCCode>
    <PackageDescription>10 PACKET in 1 BOX, UNIT-DOSE (50332-0095-6)  / .9 g in 1 PACKET</PackageDescription>
    <NDC11Code>50332-0095-06</NDC11Code>
    <ProductNDC>50332-0095</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tribiotic</ProprietaryName>
    <NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251202</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M</ApplicationNumber>
    <LabelerName>HART Health</LabelerName>
    <SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
    <StrengthNumber>400; 3.5; 5000</StrengthNumber>
    <StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis &amp; Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: First aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns, 4 abrasions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51552-0095-6</NDCCode>
    <PackageDescription>500 g in 1 CONTAINER (51552-0095-6)</PackageDescription>
    <NDC11Code>51552-0095-06</NDC11Code>
    <ProductNDC>51552-0095</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gelatin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19980401</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Fagron Inc</LabelerName>
    <SubstanceName>GELATIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>71335-0095-1</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (71335-0095-1) </PackageDescription>
    <NDC11Code>71335-0095-01</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0095-2</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (71335-0095-2) </PackageDescription>
    <NDC11Code>71335-0095-02</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0095-3</NDCCode>
    <PackageDescription>40 TABLET in 1 BOTTLE (71335-0095-3) </PackageDescription>
    <NDC11Code>71335-0095-03</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0095-4</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (71335-0095-4) </PackageDescription>
    <NDC11Code>71335-0095-04</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0095-5</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (71335-0095-5) </PackageDescription>
    <NDC11Code>71335-0095-05</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0095-7</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (71335-0095-7) </PackageDescription>
    <NDC11Code>71335-0095-07</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0095-8</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (71335-0095-8) </PackageDescription>
    <NDC11Code>71335-0095-08</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0095-9</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE (71335-0095-9) </PackageDescription>
    <NDC11Code>71335-0095-09</NDC11Code>
    <ProductNDC>71335-0095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
    <Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&amp;C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>0004-0038-22</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22)  / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00004-0038-22</NDC11Code>
    <ProductNDC>0004-0038</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valcyte</ProprietaryName>
    <NonProprietaryName>Valganciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20010329</StartMarketingDate>
    <EndMarketingDate>20250930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021304</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20010329</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
    <Description>VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>0004-0039-09</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0004-0039-09)  / 100 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>00004-0039-09</NDC11Code>
    <ProductNDC>0004-0039</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valcyte</ProprietaryName>
    <NonProprietaryName>Valganciclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090828</StartMarketingDate>
    <EndMarketingDate>20250930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022257</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20090828</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
    <Description>VALCYTE contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. VALCYTE is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®. VALCYTE is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of VALCYTE for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring. Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5∙HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-2579-20</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, GLASS (0591-2579-20) </PackageDescription>
    <NDC11Code>00591-2579-20</NDC11Code>
    <ProductNDC>0591-2579</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir Hydrochloride For Oral</ProprietaryName>
    <NonProprietaryName>Valganciclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205220</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir for oral solution is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:. Pediatric Patients (1.2) : 1 Prevention of CMV disease in kidney and heart transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir for oral solution contains valganciclovir hydrochloride USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir is available as a powder blend for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of valganciclovir for oral solution are mannitol, sodium benzoate, sucralose, tartaric acid and tutti-frutti flavoring. Valganciclovir hydrochloride, USP is a white to almost white powder. The chemical name for valganciclovir hydrochloride, USP is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir hydrochloride, USP is 7.6. The chemical structure of valganciclovir hydrochloride, USP is. C14H22N6O5·HCl        M.W. 390.83. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>0603-6330-20</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6330-20) </PackageDescription>
    <NDC11Code>00603-6330-20</NDC11Code>
    <ProductNDC>0603-6330</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir</ProprietaryName>
    <NonProprietaryName>Valganciclovir Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200790</ApplicationNumber>
    <LabelerName>Par Pharmaceutical</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir Tablets, USP are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)., 2 Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir Tablets, USP contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir Tablets, USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients colloidal silicon dioxide, crospovidone, microcrystalline cellulose, povidone K-30, and stearic acid. The film-coat applied to the tablets contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red. Valganciclovir HCl is a white to off-white amorphous powder with a molecular formula of C14H22N6O5HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-6796-04</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (0904-6796-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-6796-04</NDC11Code>
    <ProductNDC>0904-6796</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir</ProprietaryName>
    <NonProprietaryName>Valganciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205166</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:Adult Patients (1.1)  Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).  Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.Pediatric Patients (1.2)  Prevention of CMV disease in kidney and heart transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir tablets, USP contains valganciclovir hydrochloride, USP a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir tablets, USP are available as a 450 mg tablet for oral administration. Each film coated tablet contains 496.3 mg of valganciclovir hydrochloride, USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, microcrystalline cellulose, povidone and stearic acid. The tablets are coated with Opadry Pink which contains hypromellose, iron oxide red, polyethylene glycol, polysorbate 80 and titanium dioxide. Valganciclovir hydrochloride, USP is a white to off-white powder, slightly hygroscopic with a molecular formula of C14H22N6O5HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride, USP is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropylester, monohydrochloride. Valganciclovir hydrochloride, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7 and an  n-octanol/water partition coefficient of 0.0095 at pH 7. The pKa for valganciclovir hydrochloride, USP is 7.5. The chemical structure of valganciclovir hydrochloride, USP is:. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-6796-10</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (0904-6796-10)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00904-6796-10</NDC11Code>
    <ProductNDC>0904-6796</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valganciclovir</ProprietaryName>
    <NonProprietaryName>Valganciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205166</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>450</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:Adult Patients (1.1)  Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).  Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.Pediatric Patients (1.2)  Prevention of CMV disease in kidney and heart transplant patients at high risk.</IndicationAndUsage>
    <Description>Valganciclovir tablets, USP contains valganciclovir hydrochloride, USP a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir tablets, USP are available as a 450 mg tablet for oral administration. Each film coated tablet contains 496.3 mg of valganciclovir hydrochloride, USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, microcrystalline cellulose, povidone and stearic acid. The tablets are coated with Opadry Pink which contains hypromellose, iron oxide red, polyethylene glycol, polysorbate 80 and titanium dioxide. Valganciclovir hydrochloride, USP is a white to off-white powder, slightly hygroscopic with a molecular formula of C14H22N6O5HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride, USP is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropylester, monohydrochloride. Valganciclovir hydrochloride, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7 and an  n-octanol/water partition coefficient of 0.0095 at pH 7. The pKa for valganciclovir hydrochloride, USP is 7.5. The chemical structure of valganciclovir hydrochloride, USP is:. All doses in this insert are specified in terms of valganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-095-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (10544-095-14)</PackageDescription>
    <NDC11Code>10544-0095-14</NDC11Code>
    <ProductNDC>10544-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062396</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules, USP and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows. with a molecular formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Doxycycline is a light yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. 100 mg gelatin capsule shell contains: FD&amp;C Blue #1, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The printing ink contains: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Blue #2, FD&amp;C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol and Synthetic Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-095-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (10544-095-20)</PackageDescription>
    <NDC11Code>10544-0095-20</NDC11Code>
    <ProductNDC>10544-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062396</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules, USP and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows. with a molecular formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Doxycycline is a light yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. 100 mg gelatin capsule shell contains: FD&amp;C Blue #1, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The printing ink contains: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Blue #2, FD&amp;C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol and Synthetic Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-095-28</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (10544-095-28)</PackageDescription>
    <NDC11Code>10544-0095-28</NDC11Code>
    <ProductNDC>10544-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062396</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules, USP and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows. with a molecular formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Doxycycline is a light yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. 100 mg gelatin capsule shell contains: FD&amp;C Blue #1, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The printing ink contains: D&amp;C Yellow #10, FD&amp;C Blue #1, FD&amp;C Blue #2, FD&amp;C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol and Synthetic Black Iron Oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>11489-095-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (11489-095-01)  &gt; 50 g in 1 JAR</PackageDescription>
    <NDC11Code>11489-0095-01</NDC11Code>
    <ProductNDC>11489-095</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Botanics Triple Age Renewal Day Cream Sunscreen Broad Spectrum Spf 15</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>BCM Ltd</LabelerName>
    <SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>1.5; 1.5; 2.5</StrengthNumber>
    <StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13668-095-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13668-095-05) </PackageDescription>
    <NDC11Code>13668-0095-05</NDC11Code>
    <ProductNDC>13668-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090865</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1   Parkinson's disease (PD) (1.1), 2   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-095-15</NDCCode>
    <PackageDescription>1500 TABLET in 1 BOTTLE (13668-095-15) </PackageDescription>
    <NDC11Code>13668-0095-15</NDC11Code>
    <ProductNDC>13668-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090865</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1   Parkinson's disease (PD) (1.1), 2   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-095-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (13668-095-30) </PackageDescription>
    <NDC11Code>13668-0095-30</NDC11Code>
    <ProductNDC>13668-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090865</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1   Parkinson's disease (PD) (1.1), 2   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis).</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-095-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (13668-095-90) </PackageDescription>
    <NDC11Code>13668-0095-90</NDC11Code>
    <ProductNDC>13668-095</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101008</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090865</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101008</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: 1   Parkinson's disease (PD) (1.1), 2   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S·2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis).</Description>
  </NDC>
  <NDC>
    <NDCCode>14141-095-01</NDCCode>
    <PackageDescription>30 g in 1 TUBE (14141-095-01) </PackageDescription>
    <NDC11Code>14141-0095-01</NDC11Code>
    <ProductNDC>14141-095</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Medium 6</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201112</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bel Star S.A. (Colombia)</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>6.5; 2.44; 1.57</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>17312-095-19</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 PACKAGE (17312-095-19)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>17312-0095-19</NDC11Code>
    <ProductNDC>17312-095</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Red Eye Relief Pf</ProprietaryName>
    <NonProprietaryName>Apis Mellifera, Euphrasia Stricta, Calcium Sulfide, Loeselia Mexicana Whole, Pulsatilla Vulgaris</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220809</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>TRP Company</LabelerName>
    <SubstanceName>APIS MELLIFERA; CALCIUM SULFIDE; EUPHRASIA STRICTA; LOESELIA MEXICANA WHOLE; PULSATILLA VULGARIS</SubstanceName>
    <StrengthNumber>6; 12; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220809</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses:* According to homeopathic indications these ingredients provide temporary relief from symptoms such as:  Burning  Stinging  Itching  Watering  Redness  Dryness; after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
  </NDC>
</NDCList>