RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>49288-0277-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0277-3)</PackageDescription>
    <NDC11Code>49288-0277-03</NDC11Code>
    <ProductNDC>49288-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Kentucky (june) Bluegrass</ProprietaryName>
    <NonProprietaryName>Standardized Kentucky (june) Bluegrass</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103421</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>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>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0277-1</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0277-1)</PackageDescription>
    <NDC11Code>49288-0277-01</NDC11Code>
    <ProductNDC>49288-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Kentucky (june) Bluegrass</ProprietaryName>
    <NonProprietaryName>Standardized Kentucky (june) Bluegrass</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103421</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>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>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0277-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0277-2)</PackageDescription>
    <NDC11Code>49288-0277-02</NDC11Code>
    <ProductNDC>49288-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Kentucky (june) Bluegrass</ProprietaryName>
    <NonProprietaryName>Standardized Kentucky (june) Bluegrass</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103421</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>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>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0277-4</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0277-4)</PackageDescription>
    <NDC11Code>49288-0277-04</NDC11Code>
    <ProductNDC>49288-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Kentucky (june) Bluegrass</ProprietaryName>
    <NonProprietaryName>Standardized Kentucky (june) Bluegrass</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103421</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>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>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0277-5</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0277-5)</PackageDescription>
    <NDC11Code>49288-0277-05</NDC11Code>
    <ProductNDC>49288-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Kentucky (june) Bluegrass</ProprietaryName>
    <NonProprietaryName>Standardized Kentucky (june) Bluegrass</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103421</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>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>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>15631-0277-3</NDCCode>
    <PackageDescription>750 PELLET in 1 PACKAGE (15631-0277-3) </PackageDescription>
    <NDC11Code>15631-0277-03</NDC11Code>
    <ProductNDC>15631-0277</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lobelia Inflata</ProprietaryName>
    <NonProprietaryName>Lobelia Inflata</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150907</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>LOBELIA INFLATA</SubstanceName>
    <StrengthNumber>3</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>37662-0277-3</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-0277-3) </PackageDescription>
    <NDC11Code>37662-0277-03</NDC11Code>
    <ProductNDC>37662-0277</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chromium Oxydatum</ProprietaryName>
    <NonProprietaryName>Chromium Oxydatum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220602</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>CHROMIC OXIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49580-0277-3</NDCCode>
    <PackageDescription>946 mL in 1 BOTTLE, PLASTIC (49580-0277-3) </PackageDescription>
    <NDC11Code>49580-0277-03</NDC11Code>
    <ProductNDC>49580-0277</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Isopropyl Alcohol</ProprietaryName>
    <ProprietaryNameSuffix>91 Percent Readyincase</ProprietaryNameSuffix>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140831</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>P &amp; L Development, LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>91</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140831</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent the risk of infection in minor cuts, scrapes and burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54569-0277-3</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (54569-0277-3)</PackageDescription>
    <NDC11Code>54569-0277-03</NDC11Code>
    <ProductNDC>54569-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Indomethacin</ProprietaryName>
    <NonProprietaryName>Indomethacin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091276</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>INDOMETHACIN</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58118-0277-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (58118-0277-3)</PackageDescription>
    <NDC11Code>58118-0277-03</NDC11Code>
    <ProductNDC>58118-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Januvia</ProprietaryName>
    <NonProprietaryName>Sitagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061016</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021995</ApplicationNumber>
    <LabelerName>Clinical Solutions Wholesale</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
    <IndicationAndUsage>JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1.1). Important Limitations of Use: 1 JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. (1.2), 2 JANUVIA has not been studied in patients with a history of pancreatitis. (1.2, 5.1).</IndicationAndUsage>
    <Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62011-0277-3</NDCCode>
    <PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (62011-0277-3) </PackageDescription>
    <NDC11Code>62011-0277-03</NDC11Code>
    <ProductNDC>62011-0277</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Laxative</ProprietaryName>
    <NonProprietaryName>Bisacodyl</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020325</StartMarketingDate>
    <EndMarketingDate>20250316</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Strategic Sourcing Services, LLC (Health Mart)</LabelerName>
    <SubstanceName>BISACODYL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20020325</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241208</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71335-0277-3</NDCCode>
    <PackageDescription>40 TABLET in 1 BOTTLE (71335-0277-3) </PackageDescription>
    <NDC11Code>71335-0277-03</NDC11Code>
    <ProductNDC>71335-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071141</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>80425-0277-3</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (80425-0277-3) </PackageDescription>
    <NDC11Code>80425-0277-03</NDC11Code>
    <ProductNDC>80425-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208677</ApplicationNumber>
    <LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&amp;C Blue 1, FD&amp;C Red 40 and FD&amp;C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0277-02</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 DOSE PACK (0006-0277-02) </PackageDescription>
    <NDC11Code>00006-0277-02</NDC11Code>
    <ProductNDC>0006-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Januvia</ProprietaryName>
    <NonProprietaryName>Sitagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061016</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021995</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0277-14</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (0006-0277-14)  / 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00006-0277-14</NDC11Code>
    <ProductNDC>0006-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Januvia</ProprietaryName>
    <NonProprietaryName>Sitagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061016</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021995</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0277-28</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (0006-0277-28)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0277-01) </PackageDescription>
    <NDC11Code>00006-0277-28</NDC11Code>
    <ProductNDC>0006-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Januvia</ProprietaryName>
    <NonProprietaryName>Sitagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061016</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021995</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0277-31</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-0277-31) </PackageDescription>
    <NDC11Code>00006-0277-31</NDC11Code>
    <ProductNDC>0006-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Januvia</ProprietaryName>
    <NonProprietaryName>Sitagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061016</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021995</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0277-33</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 DOSE PACK (0006-0277-33) </PackageDescription>
    <NDC11Code>00006-0277-33</NDC11Code>
    <ProductNDC>0006-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Januvia</ProprietaryName>
    <NonProprietaryName>Sitagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061016</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021995</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0277-54</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0006-0277-54) </PackageDescription>
    <NDC11Code>00006-0277-54</NDC11Code>
    <ProductNDC>0006-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Januvia</ProprietaryName>
    <NonProprietaryName>Sitagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061016</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021995</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-0277-82</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0006-0277-82) </PackageDescription>
    <NDC11Code>00006-0277-82</NDC11Code>
    <ProductNDC>0006-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Januvia</ProprietaryName>
    <NonProprietaryName>Sitagliptin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061016</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021995</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061016</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0277-02</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0069-0277-02)  / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00069-0277-02</NDC11Code>
    <ProductNDC>0069-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240819</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050629</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: 1 as a component of multi‑agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1), 2 for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).</IndicationAndUsage>
    <Description>Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride is 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The chemical structure of doxorubicin hydrochloride is. Doxorubicin Hydrochloride Injection, for intravenous use is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride (equivalent to 46.86 mg of doxorubicin free base), 150 mg/75 mL doxorubicin hydrochloride (140.58 mg of doxorubicin free base), or 200 mg/100 mL doxorubicin hydrochloride (equivalent to 187.4 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride and 9 mg of sodium chloride. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0168-0277-40</NDCCode>
    <PackageDescription>40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40) </PackageDescription>
    <NDC11Code>00168-0277-40</NDC11Code>
    <ProductNDC>0168-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phosphate</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20041227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065139</ApplicationNumber>
    <LabelerName>E. Fougera &amp; Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20041227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (See CLINICAL STUDIES.). NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, eg, Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.</IndicationAndUsage>
    <Description>Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C18H34ClN2O8PS. The structural formula is represented below. Clindamycin phosphate vaginal cream USP, 2%, is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. The pH of the cream is between 3.0 and 6.0. The cream also contains benzyl alcohol, cetostearyl alcohol, cetyl palmitate, mineral oil, polysorbate 60, propylene glycol, sorbitan monostearate, stearic acid and purified water. Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0185-0277-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0185-0277-01) </PackageDescription>
    <NDC11Code>00185-0277-01</NDC11Code>
    <ProductNDC>0185-0277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076631</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>20; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (&gt;100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5- tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its molecular formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide's chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is. Its molecular formula is C7H8ClN3O4S2, and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. The tablets are a combination of benazepril hydrochloride and hydrochlorothiazide, USP. They are formulated for oral administration with a combination of 5 mg, 10 mg, or 20 mg of benazepril hydrochloride and 6.25 mg, 12.5 mg, or 25 mg of hydrochlorothiazide, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, lactose monohydrate, poloxamer, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and zinc stearate. The 5 mg/6.25 mg tablets also contain polyvinyl alcohol - part hydrolyzed and talc. The 10 mg/12.5 mg tablets also contain FD&amp;C red No. 40, FD&amp;C yellow No. 6, polyvinyl alcohol and talc. The 20 mg/12.5 mg tablets also contain FD&amp;C blue No. 2, FD&amp;C red No. 40, hypromellose and polysorbate. The 20 mg/25 mg tablets also contain FD&amp;C red No. 40, hypromellose and polysorbate. This product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-277-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (10544-277-14)</PackageDescription>
    <NDC11Code>10544-0277-14</NDC11Code>
    <ProductNDC>10544-277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.</IndicationAndUsage>
    <Description>Naproxen USP is a proprionic 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 and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-277-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (10544-277-20)</PackageDescription>
    <NDC11Code>10544-0277-20</NDC11Code>
    <ProductNDC>10544-277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.</IndicationAndUsage>
    <Description>Naproxen USP is a proprionic 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 and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-277-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (10544-277-30)</PackageDescription>
    <NDC11Code>10544-0277-30</NDC11Code>
    <ProductNDC>10544-277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078250</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.</IndicationAndUsage>
    <Description>Naproxen USP is a proprionic 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 and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544.</Description>
  </NDC>
  <NDC>
    <NDCCode>14783-277-01</NDCCode>
    <PackageDescription>10 g in 1 BOTTLE (14783-277-01) </PackageDescription>
    <NDC11Code>14783-0277-01</NDC11Code>
    <ProductNDC>14783-277</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Double Use Compact Spf 15 Gold Deluxe Edition Medium 5</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201112</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>4.9; 6.24; 3</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>15631-0277-0</NDCCode>
    <PackageDescription>100 PELLET in 1 PACKAGE (15631-0277-0) </PackageDescription>
    <NDC11Code>15631-0277-00</NDC11Code>
    <ProductNDC>15631-0277</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lobelia Inflata</ProprietaryName>
    <NonProprietaryName>Lobelia Inflata</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150907</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>LOBELIA INFLATA</SubstanceName>
    <StrengthNumber>3</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>15631-0277-1</NDCCode>
    <PackageDescription>200 PELLET in 1 PACKAGE (15631-0277-1) </PackageDescription>
    <NDC11Code>15631-0277-01</NDC11Code>
    <ProductNDC>15631-0277</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lobelia Inflata</ProprietaryName>
    <NonProprietaryName>Lobelia Inflata</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150907</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>LOBELIA INFLATA</SubstanceName>
    <StrengthNumber>3</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>15631-0277-2</NDCCode>
    <PackageDescription>400 PELLET in 1 PACKAGE (15631-0277-2) </PackageDescription>
    <NDC11Code>15631-0277-02</NDC11Code>
    <ProductNDC>15631-0277</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lobelia Inflata</ProprietaryName>
    <NonProprietaryName>Lobelia Inflata</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150907</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>LOBELIA INFLATA</SubstanceName>
    <StrengthNumber>3</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>
</NDCList>