RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>62128-0392-5</NDCCode>
    <PackageDescription>1150 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (62128-0392-5) </PackageDescription>
    <NDC11Code>62128-0392-05</NDC11Code>
    <ProductNDC>62128-0392</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ractopamine Hydrochloric Acid</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <StartMarketingDate>19921201</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Evonik Corporation</LabelerName>
    <SubstanceName>RACTOPAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-12-12</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-DEC-92</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>62128-0392-4</NDCCode>
    <PackageDescription>950 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (62128-0392-4)</PackageDescription>
    <NDC11Code>62128-0392-04</NDC11Code>
    <ProductNDC>62128-0392</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ractopamine Hydrochloric Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>19921201</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Evonik Corporation</LabelerName>
    <SubstanceName>RACTOPAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62128-0385-5</NDCCode>
    <PackageDescription>17 kg in 1 DRUM (62128-0385-5) </PackageDescription>
    <NDC11Code>62128-0385-05</NDC11Code>
    <ProductNDC>62128-0385</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20031126</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Evonik Corporation</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-12-12</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>26-NOV-03</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>62128-0389-5</NDCCode>
    <PackageDescription>1100 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (62128-0389-5) </PackageDescription>
    <NDC11Code>62128-0389-05</NDC11Code>
    <ProductNDC>62128-0389</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tilmicosin Aqueous</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>19961202</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Evonik Corporation</LabelerName>
    <SubstanceName>TILMICOSIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-07-10</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-DEC-96</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>62128-0394-1</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (62128-0394-1) </PackageDescription>
    <NDC11Code>62128-0394-01</NDC11Code>
    <ProductNDC>62128-0394</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20211202</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Evonik Corporation</LabelerName>
    <SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-05-21</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-MAR-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11822-0392-5</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (11822-0392-5)  &gt; 50 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>11822-0392-05</NDC11Code>
    <ProductNDC>11822-0392</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Relief Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020330</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075139</ApplicationNumber>
    <LabelerName>Rite Aid Corporation</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>15631-0392-5</NDCCode>
    <PackageDescription>12500 PELLET in 1 PACKAGE (15631-0392-5) </PackageDescription>
    <NDC11Code>15631-0392-05</NDC11Code>
    <ProductNDC>15631-0392</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sarcolacticum Acidum</ProprietaryName>
    <NonProprietaryName>Sarcolacticum Acidum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151031</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>LACTIC ACID, L-</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>17856-0392-1</NDCCode>
    <PackageDescription>60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-0392-01</NDC11Code>
    <ProductNDC>17856-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040180</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
    <Description>Each mL for oral administration contains 10 mg methadone hydrochloride USP. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder that is water soluble. Its molecular formula is C 21H 27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Each mL of the unflavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, sodium benzoate and water. Each mL of the cherry flavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, cherry pistachio flavor, D&amp;C Red #33, FD&amp;C Red #40, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution, sucrose and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0392-3</NDCCode>
    <PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0392-3)  / 2.5 mL in 1 CUP, UNIT-DOSE (17856-0392-4) </PackageDescription>
    <NDC11Code>17856-0392-03</NDC11Code>
    <ProductNDC>17856-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040180</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
    <Description>Each mL for oral administration contains 10 mg methadone hydrochloride USP. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder that is water soluble. Its molecular formula is C 21H 27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Each mL of the unflavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, sodium benzoate and water. Each mL of the cherry flavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, cherry pistachio flavor, D&amp;C Red #33, FD&amp;C Red #40, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution, sucrose and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0392-6</NDCCode>
    <PackageDescription>1 SYRINGE in 1 BAG (17856-0392-6)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-0392-06</NDC11Code>
    <ProductNDC>17856-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040180</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
    <Description>Each mL for oral administration contains 10 mg methadone hydrochloride USP. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder that is water soluble. Its molecular formula is C 21H 27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Each mL of the unflavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, sodium benzoate and water. Each mL of the cherry flavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, cherry pistachio flavor, D&amp;C Red #33, FD&amp;C Red #40, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution, sucrose and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0392-7</NDCCode>
    <PackageDescription>5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0392-7)  / 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2)  / 1 mL in 1 SYRINGE (17856-0392-5) </PackageDescription>
    <NDC11Code>17856-0392-07</NDC11Code>
    <ProductNDC>17856-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040180</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
    <Description>Each mL for oral administration contains 10 mg methadone hydrochloride USP. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder that is water soluble. Its molecular formula is C 21H 27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Each mL of the unflavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, sodium benzoate and water. Each mL of the cherry flavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, cherry pistachio flavor, D&amp;C Red #33, FD&amp;C Red #40, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution, sucrose and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>17856-0392-9</NDCCode>
    <PackageDescription>1 SYRINGE in 1 BAG (17856-0392-9)  / 2.5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-0392-09</NDC11Code>
    <ProductNDC>17856-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040180</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
    <Description>Each mL for oral administration contains 10 mg methadone hydrochloride USP. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder that is water soluble. Its molecular formula is C 21H 27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Each mL of the unflavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, sodium benzoate and water. Each mL of the cherry flavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, cherry pistachio flavor, D&amp;C Red #33, FD&amp;C Red #40, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution, sucrose and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0392-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0392-2)</PackageDescription>
    <NDC11Code>49288-0392-02</NDC11Code>
    <ProductNDC>49288-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pecan Pollen</ProprietaryName>
    <NonProprietaryName>Pecan Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CARYA ILLINOINENSIS POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0392-5</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0392-5)</PackageDescription>
    <NDC11Code>49288-0392-05</NDC11Code>
    <ProductNDC>49288-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pecan Pollen</ProprietaryName>
    <NonProprietaryName>Pecan Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CARYA ILLINOINENSIS POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>70518-0392-0</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70518-0392-0)  / 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>70518-0392-00</NDC11Code>
    <ProductNDC>70518-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Erythromycin</ProprietaryName>
    <NonProprietaryName>Erythromycin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20170404</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062447</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>ERYTHROMYCIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170404</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeaeor C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrheaeis not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.</IndicationAndUsage>
    <Description>Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-dideoxy-3- C-methyl-3- 0-methyl-α-L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione) is antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula:. Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0392-5</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-5) </PackageDescription>
    <NDC11Code>71335-0392-05</NDC11Code>
    <ProductNDC>71335-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
    <NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140611</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203088</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
    <Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&amp;C Blue No. 1, FD&amp;C Yellow No. 6, and FD&amp;C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&amp;C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&amp;C Blue No. 1, FD&amp;C Yellow No. 6, FD&amp;C Yellow No.10, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0392-68</NDCCode>
    <PackageDescription>1000 mL in 1 BOTTLE (0054-0392-68) </PackageDescription>
    <NDC11Code>00054-0392-68</NDC11Code>
    <ProductNDC>0054-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040180</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methadone hydrochloride oral concentrate contains methadone, an opioid agonist indicated for the: 1 detoxification treatment of opioid addiction (heroin or other morphine-like drugs)., 2 maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
    <Description>Methadone hydrochloride oral concentrate, USP contains methadone, an opioid agonist. Each mL for oral administration contains 10 mg methadone hydrochloride, USP. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride, USP is a white powder that is water soluble. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Each mL of the unflavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride, USP. The inactive ingredients are: citric acid, sodium benzoate and water. Each mL of the cherry flavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride, USP. The inactive ingredients are: citric acid, cherry pistachio flavor, D&amp;C Red #33, FD&amp;C Red #40, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution, sucrose and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>0462-0392-02</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0462-0392-02)  &gt; 59 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00462-0392-02</NDC11Code>
    <ProductNDC>0462-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lokara</ProprietaryName>
    <NonProprietaryName>Desonide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075860</ApplicationNumber>
    <LabelerName>E. Fougera &amp; Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LoKara Lotion (desonide lotion 0.05%) is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>LoKara Lotion (desonide lotion 0.05%) contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α-) a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents. Chemically, desonide is C24H32O6. It has the following structural formula:. Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of LoKara Lotion (desonide lotion 0.05%) contains 0.5 mg of desonide in a base of sodium lauryl sulfate, light mineral oil, cetyl alcohol, stearyl alcohol, propylene glycol, methylparaben, propylparaben, sorbitan monostearate, glyceryl stearate SE, edetate sodium, citric acid anhydrous and purified water. May also contain additional citric acid and/or sodium hydroxide for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>0462-0392-04</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0462-0392-04)  &gt; 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00462-0392-04</NDC11Code>
    <ProductNDC>0462-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lokara</ProprietaryName>
    <NonProprietaryName>Desonide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20020319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075860</ApplicationNumber>
    <LabelerName>E. Fougera &amp; Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LoKara Lotion (desonide lotion 0.05%) is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>LoKara Lotion (desonide lotion 0.05%) contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α-) a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents. Chemically, desonide is C24H32O6. It has the following structural formula:. Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of LoKara Lotion (desonide lotion 0.05%) contains 0.5 mg of desonide in a base of sodium lauryl sulfate, light mineral oil, cetyl alcohol, stearyl alcohol, propylene glycol, methylparaben, propylparaben, sorbitan monostearate, glyceryl stearate SE, edetate sodium, citric acid anhydrous and purified water. May also contain additional citric acid and/or sodium hydroxide for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>11014-0392-1</NDCCode>
    <PackageDescription>1 BAG in 1 CARTON (11014-0392-1)  / 12000 CAPSULE in 1 BAG</PackageDescription>
    <NDC11Code>11014-0392-01</NDC11Code>
    <ProductNDC>11014-0392</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dutasteride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20190623</StartMarketingDate>
    <MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
    <LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
    <SubstanceName>DUTASTERIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-05-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-JUN-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>17856-0392-8</NDCCode>
    <PackageDescription>1 SYRINGE in 1 BAG (17856-0392-8)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>17856-0392-08</NDC11Code>
    <ProductNDC>17856-0392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>CONCENTRATE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040180</ApplicationNumber>
    <LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250530</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
    <Description>Each mL for oral administration contains 10 mg methadone hydrochloride USP. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder that is water soluble. Its molecular formula is C 21H 27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Each mL of the unflavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, sodium benzoate and water. Each mL of the cherry flavored liquid concentrate, for oral administration, contains 10 mg of methadone hydrochloride USP. The inactive ingredients are: citric acid, cherry pistachio flavor, D&amp;C Red #33, FD&amp;C Red #40, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution, sucrose and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-392-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (31722-392-30) </PackageDescription>
    <NDC11Code>31722-0392-30</NDC11Code>
    <ProductNDC>31722-392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prucalopride</ProprietaryName>
    <NonProprietaryName>Prucalopride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219160</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
    <Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide butanedioate. The molecular formula is C 18H 26ClN 3O 3.C 4H 6O 4and the molecular weight is 485.96. The structural formula is:. Prucalopride succinate is a white to an off-white powder. It is soluble in dimethyl sulphoxide and water. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and triacetin. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-392-05</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (33342-392-05) </PackageDescription>
    <NDC11Code>33342-0392-05</NDC11Code>
    <ProductNDC>33342-392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211418</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets 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. Treatment: Doxycycline is indicated for the treatment of the following infections:  Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.  Respiratory tract infections caused by Mycoplasma pneumoniae.  Lymphogranuloma venereum caused by Chlamydia trachomatis.  Psittacosis (ornithosis) caused by Chlamydophila psittaci.  Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.  Inclusion conjunctivitis caused by Chlamydia trachomatis.  Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.  Nongonococcal urethritis caused by Ureaplasma urealyticum.  Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms.  Chancroid caused by Haemophilus ducreyi.  Plague due to Yersinia pestis.  Tularemia due to Francisella tularensis.  Cholera caused by Vibrio cholerae.  Campylobacter fetus infections caused by Campylobacter fetus.  Brucellosis due to Brucella species (in conjunction with streptomycin).  Bartonellosis due to Bartonella bacilliformis.  Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:.  Escherichia coli.  Enterobacter aerogenes. Shigella species.  Acinetobacter species.  Respiratory tract infections caused by Haemophilus influenzae.  Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:.  Upper respiratory infections caused by Streptococcus pneumoniae.  Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:    Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.  Yaws caused by Treponema pallidum subspecies pertenue.  Listeriosis due to Listeria monocytogenes.  Vincent’s infection caused by Fusobacterium fusiforme.  Actinomycosis caused by Actinomyces israelii.  Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (&lt;4 months) to areas withchloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).</IndicationAndUsage>
    <Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8 . HCl)2 . C2H6O . H2O and the molecular weight is 1025.89. The chemical designation for doxycycline hyclate 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 monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline Hyclate light-yellowish 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. Inert ingredients in the tablet formulations are: microcrystalline cellulose colloidal silicon dioxide, croscarmellose sodium, pregelatinized Starch, Sodium Stearyl fumarate, and magnesium stearate, The coating material contain, Hypromellose, Polyethylene Glycol 400, titanium dioxide, and FD and C Yellow No. 6 Al. Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-392-08</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (33342-392-08) </PackageDescription>
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    <ProductNDC>33342-392</ProductNDC>
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    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
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    <ApplicationNumber>ANDA211418</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
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    <LastUpdate>2026-01-07</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets 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. Treatment: Doxycycline is indicated for the treatment of the following infections:  Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.  Respiratory tract infections caused by Mycoplasma pneumoniae.  Lymphogranuloma venereum caused by Chlamydia trachomatis.  Psittacosis (ornithosis) caused by Chlamydophila psittaci.  Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.  Inclusion conjunctivitis caused by Chlamydia trachomatis.  Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.  Nongonococcal urethritis caused by Ureaplasma urealyticum.  Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms.  Chancroid caused by Haemophilus ducreyi.  Plague due to Yersinia pestis.  Tularemia due to Francisella tularensis.  Cholera caused by Vibrio cholerae.  Campylobacter fetus infections caused by Campylobacter fetus.  Brucellosis due to Brucella species (in conjunction with streptomycin).  Bartonellosis due to Bartonella bacilliformis.  Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:.  Escherichia coli.  Enterobacter aerogenes. Shigella species.  Acinetobacter species.  Respiratory tract infections caused by Haemophilus influenzae.  Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:.  Upper respiratory infections caused by Streptococcus pneumoniae.  Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:    Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.  Yaws caused by Treponema pallidum subspecies pertenue.  Listeriosis due to Listeria monocytogenes.  Vincent’s infection caused by Fusobacterium fusiforme.  Actinomycosis caused by Actinomyces israelii.  Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (&lt;4 months) to areas withchloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).</IndicationAndUsage>
    <Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8 . HCl)2 . C2H6O . H2O and the molecular weight is 1025.89. The chemical designation for doxycycline hyclate 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 monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline Hyclate light-yellowish 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. Inert ingredients in the tablet formulations are: microcrystalline cellulose colloidal silicon dioxide, croscarmellose sodium, pregelatinized Starch, Sodium Stearyl fumarate, and magnesium stearate, The coating material contain, Hypromellose, Polyethylene Glycol 400, titanium dioxide, and FD and C Yellow No. 6 Al. Lake.</Description>
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    <PackageDescription>100 TABLET in 1 BOTTLE (33342-392-11) </PackageDescription>
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    <ApplicationNumber>ANDA211418</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
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    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets 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. Treatment: Doxycycline is indicated for the treatment of the following infections:  Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.  Respiratory tract infections caused by Mycoplasma pneumoniae.  Lymphogranuloma venereum caused by Chlamydia trachomatis.  Psittacosis (ornithosis) caused by Chlamydophila psittaci.  Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.  Inclusion conjunctivitis caused by Chlamydia trachomatis.  Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.  Nongonococcal urethritis caused by Ureaplasma urealyticum.  Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms.  Chancroid caused by Haemophilus ducreyi.  Plague due to Yersinia pestis.  Tularemia due to Francisella tularensis.  Cholera caused by Vibrio cholerae.  Campylobacter fetus infections caused by Campylobacter fetus.  Brucellosis due to Brucella species (in conjunction with streptomycin).  Bartonellosis due to Bartonella bacilliformis.  Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:.  Escherichia coli.  Enterobacter aerogenes. Shigella species.  Acinetobacter species.  Respiratory tract infections caused by Haemophilus influenzae.  Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:.  Upper respiratory infections caused by Streptococcus pneumoniae.  Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:    Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.  Yaws caused by Treponema pallidum subspecies pertenue.  Listeriosis due to Listeria monocytogenes.  Vincent’s infection caused by Fusobacterium fusiforme.  Actinomycosis caused by Actinomyces israelii.  Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (&lt;4 months) to areas withchloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).</IndicationAndUsage>
    <Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8 . HCl)2 . C2H6O . H2O and the molecular weight is 1025.89. The chemical designation for doxycycline hyclate 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 monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline Hyclate light-yellowish 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. Inert ingredients in the tablet formulations are: microcrystalline cellulose colloidal silicon dioxide, croscarmellose sodium, pregelatinized Starch, Sodium Stearyl fumarate, and magnesium stearate, The coating material contain, Hypromellose, Polyethylene Glycol 400, titanium dioxide, and FD and C Yellow No. 6 Al. Lake.</Description>
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    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
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    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets 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. Treatment: Doxycycline is indicated for the treatment of the following infections:  Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.  Respiratory tract infections caused by Mycoplasma pneumoniae.  Lymphogranuloma venereum caused by Chlamydia trachomatis.  Psittacosis (ornithosis) caused by Chlamydophila psittaci.  Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.  Inclusion conjunctivitis caused by Chlamydia trachomatis.  Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.  Nongonococcal urethritis caused by Ureaplasma urealyticum.  Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms.  Chancroid caused by Haemophilus ducreyi.  Plague due to Yersinia pestis.  Tularemia due to Francisella tularensis.  Cholera caused by Vibrio cholerae.  Campylobacter fetus infections caused by Campylobacter fetus.  Brucellosis due to Brucella species (in conjunction with streptomycin).  Bartonellosis due to Bartonella bacilliformis.  Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:.  Escherichia coli.  Enterobacter aerogenes. Shigella species.  Acinetobacter species.  Respiratory tract infections caused by Haemophilus influenzae.  Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:.  Upper respiratory infections caused by Streptococcus pneumoniae.  Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:    Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.  Yaws caused by Treponema pallidum subspecies pertenue.  Listeriosis due to Listeria monocytogenes.  Vincent’s infection caused by Fusobacterium fusiforme.  Actinomycosis caused by Actinomyces israelii.  Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (&lt;4 months) to areas withchloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).</IndicationAndUsage>
    <Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8 . HCl)2 . C2H6O . H2O and the molecular weight is 1025.89. The chemical designation for doxycycline hyclate 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 monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline Hyclate light-yellowish 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. Inert ingredients in the tablet formulations are: microcrystalline cellulose colloidal silicon dioxide, croscarmellose sodium, pregelatinized Starch, Sodium Stearyl fumarate, and magnesium stearate, The coating material contain, Hypromellose, Polyethylene Glycol 400, titanium dioxide, and FD and C Yellow No. 6 Al. Lake.</Description>
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    <StartMarketingDatePackage>20251119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets 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. Treatment: Doxycycline is indicated for the treatment of the following infections:  Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.  Respiratory tract infections caused by Mycoplasma pneumoniae.  Lymphogranuloma venereum caused by Chlamydia trachomatis.  Psittacosis (ornithosis) caused by Chlamydophila psittaci.  Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.  Inclusion conjunctivitis caused by Chlamydia trachomatis.  Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis.  Nongonococcal urethritis caused by Ureaplasma urealyticum.  Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms.  Chancroid caused by Haemophilus ducreyi.  Plague due to Yersinia pestis.  Tularemia due to Francisella tularensis.  Cholera caused by Vibrio cholerae.  Campylobacter fetus infections caused by Campylobacter fetus.  Brucellosis due to Brucella species (in conjunction with streptomycin).  Bartonellosis due to Bartonella bacilliformis.  Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug:.  Escherichia coli.  Enterobacter aerogenes. Shigella species.  Acinetobacter species.  Respiratory tract infections caused by Haemophilus influenzae.  Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:.  Upper respiratory infections caused by Streptococcus pneumoniae.  Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:    Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.  Syphilis caused by Treponema pallidum.  Yaws caused by Treponema pallidum subspecies pertenue.  Listeriosis due to Listeria monocytogenes.  Vincent’s infection caused by Fusobacterium fusiforme.  Actinomycosis caused by Actinomyces israelii.  Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (&lt;4 months) to areas withchloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.).</IndicationAndUsage>
    <Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate); for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8 . HCl)2 . C2H6O . H2O and the molecular weight is 1025.89. The chemical designation for doxycycline hyclate 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 monohydrochloride, compound with ethyl alcohol (2: 1), monohydrate. Doxycycline Hyclate light-yellowish 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. Inert ingredients in the tablet formulations are: microcrystalline cellulose colloidal silicon dioxide, croscarmellose sodium, pregelatinized Starch, Sodium Stearyl fumarate, and magnesium stearate, The coating material contain, Hypromellose, Polyethylene Glycol 400, titanium dioxide, and FD and C Yellow No. 6 Al. Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-392-01</NDCCode>
    <PackageDescription>1.5 mL in 1 POUCH (37000-392-01)</PackageDescription>
    <NDC11Code>37000-0392-01</NDC11Code>
    <ProductNDC>37000-392</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dolce And Gabbana The Primer Sheer Radiance</ProprietaryName>
    <ProprietaryNameSuffix>Make Up Base With Sunscreen Broad Spectrum Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Ensulizole, Octinoxate, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140424</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>ENSULIZOLE; OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>1; 7.49; 3.92</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-12-11</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>37808-392-03</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (37808-392-03)  &gt; 5 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>37808-0392-03</NDC11Code>
    <ProductNDC>37808-392</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Allergy Relief</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211075</ApplicationNumber>
    <LabelerName>HEB</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43547-392-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (43547-392-03) </PackageDescription>
    <NDC11Code>43547-0392-03</NDC11Code>
    <ProductNDC>43547-392</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170424</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207804</ApplicationNumber>
    <LabelerName>Solco Healthcare US, LLC</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>40; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration (2)]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive drugs. Limitations of Use. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension.</IndicationAndUsage>
    <Description>Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide, USP is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil, USP, combined with 12.5 mg of hydrochlorothiazide, USP, or 40 mg of olmesartan medoxomil, USP, combined with 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide. Black iron oxide, red iron oxide and yellow iron oxide are also added to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets.</Description>
  </NDC>
</NDCList>