RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>49288-0229-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0229-2)</PackageDescription>
    <NDC11Code>49288-0229-02</NDC11Code>
    <ProductNDC>49288-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guinea Pig Hair</ProprietaryName>
    <NonProprietaryName>Guinea Pig Hair</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CAVIA PORCELLUS HAIR</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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>49288-0229-5</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0229-5)</PackageDescription>
    <NDC11Code>49288-0229-05</NDC11Code>
    <ProductNDC>49288-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guinea Pig Hair</ProprietaryName>
    <NonProprietaryName>Guinea Pig Hair</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CAVIA PORCELLUS HAIR</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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>49288-0229-1</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0229-1)</PackageDescription>
    <NDC11Code>49288-0229-01</NDC11Code>
    <ProductNDC>49288-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guinea Pig Hair</ProprietaryName>
    <NonProprietaryName>Guinea Pig Hair</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CAVIA PORCELLUS HAIR</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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>49288-0229-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0229-3)</PackageDescription>
    <NDC11Code>49288-0229-03</NDC11Code>
    <ProductNDC>49288-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guinea Pig Hair</ProprietaryName>
    <NonProprietaryName>Guinea Pig Hair</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CAVIA PORCELLUS HAIR</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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>49288-0229-4</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0229-4)</PackageDescription>
    <NDC11Code>49288-0229-04</NDC11Code>
    <ProductNDC>49288-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Guinea Pig Hair</ProprietaryName>
    <NonProprietaryName>Guinea Pig Hair</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920413</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>CAVIA PORCELLUS HAIR</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Animal Fur [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>15631-0229-5</NDCCode>
    <PackageDescription>12500 PELLET in 1 PACKAGE (15631-0229-5) </PackageDescription>
    <NDC11Code>15631-0229-05</NDC11Code>
    <ProductNDC>15631-0229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hypericum Perforatum</ProprietaryName>
    <NonProprietaryName>Hypericum Perforatum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151002</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>HYPERICUM PERFORATUM</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2021-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54868-0229-5</NDCCode>
    <PackageDescription>40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0229-5)</PackageDescription>
    <NDC11Code>54868-0229-05</NDC11Code>
    <ProductNDC>54868-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040804</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydrOXYzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. HydrOXYzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydrOXYzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>HydrOXYzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. HydrOXYzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydrOXYzine HCI. Inactive ingredients include: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0229-5</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (71335-0229-5) </PackageDescription>
    <NDC11Code>71335-0229-05</NDC11Code>
    <ProductNDC>71335-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20041223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076855</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-03-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>80425-0229-1</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (80425-0229-1)  / 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>80425-0229-01</NDC11Code>
    <ProductNDC>80425-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neomycin And Polymyxin B Sulfates And Dexamethasone</ProprietaryName>
    <NonProprietaryName>Neomycin And Polymyxin B Sulfates And Dexamethasone</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20230111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064063</ApplicationNumber>
    <LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE</SubstanceName>
    <StrengthNumber>3.5; 10000; 1</StrengthNumber>
    <StrengthUnit>mg/g; [USP'U]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
    <Description>Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is. The chemical structure for the active ingredient Polymyxin B Sulfate is:. The chemical structure for the active ingredient Dexamethasone is:. Established Name: Dexamethasone Chemical Name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17, 21-trihydroxy-16-methyl-, (11β, 16α) -. Each gram contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: white petrolatum, lanolin, mineral oil.</Description>
  </NDC>
  <NDC>
    <NDCCode>0316-0229-75</NDCCode>
    <PackageDescription>222 mL in 1 BOTTLE, PUMP (0316-0229-75) </PackageDescription>
    <NDC11Code>00316-0229-75</NDC11Code>
    <ProductNDC>0316-0229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sarna</ProprietaryName>
    <NonProprietaryName>Camphor And Menthol</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110222</StartMarketingDate>
    <EndMarketingDate>20260228</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Crown Laboratories</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>5; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0574-0229-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0574-0229-01) </PackageDescription>
    <NDC11Code>00574-0229-01</NDC11Code>
    <ProductNDC>0574-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190407</StartMarketingDate>
    <EndMarketingDate>20270930</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020033</ApplicationNumber>
    <LabelerName>Padagis US LLC</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>20; 12.5</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>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190407</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril HCl and Hydrochlorothiazide is 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 empirical formula is C24H28N2O5·HCl, 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 empirical formula is C7 H8 ClN3 O4 S2, and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. Benazepril HCl and Hydrochlorothiazide is a combination of benazepril and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 10 or 20 mg of benazepril and 12.5 or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablets are cellulose compounds, crospovidone, hydrogenated castor oil, iron oxides (10/12.5 mg, 20/12.5 mg, and 20/25 mg tablets), lactose, polyethylene glycol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0713-0229-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0713-0229-15)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>00713-0229-15</NDC11Code>
    <ProductNDC>0713-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089795</ApplicationNumber>
    <LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6,  M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0713-0229-80</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (0713-0229-80)  / 80 g in 1 TUBE</PackageDescription>
    <NDC11Code>00713-0229-80</NDC11Code>
    <ProductNDC>0713-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089795</ApplicationNumber>
    <LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16ą)-. C 24H 31FO 6,  M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1% contains 0.25 mg or 1 mg triamcinolone acetonide USP, respectively, in an ointment base consisting of light mineral oil NF and white petrolatum USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-0229-00</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0229-00) </PackageDescription>
    <NDC11Code>00832-0229-00</NDC11Code>
    <ProductNDC>0832-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202104</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
    <Description>Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&amp;C blue #1, FD&amp;C red #40 (10 mg); D&amp;C yellow #10 (20 mg); FD&amp;C blue #1, FD&amp;C red #40 (30 mg); FD&amp;C blue #1, FD&amp;C red #40 (50 mg); FD&amp;C blue #1, FD&amp;C red #40 (60 mg); FD&amp;C red #40, FD&amp;C yellow #6 (80 mg); FD&amp;C yellow #10, FD&amp;C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-0229-50</NDCCode>
    <PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0229-50) </PackageDescription>
    <NDC11Code>00832-0229-50</NDC11Code>
    <ProductNDC>0832-0229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202104</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.</IndicationAndUsage>
    <Description>Morphine sulfate extended-release capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP. The following inactive ingredients are common to all strengths: hypromellose, microcrystalline cellulose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, and talc. The capsule shells contain gelatin, titanium dioxide, and black ink. In addition, individual capsules contain: FD&amp;C blue #1, FD&amp;C red #40 (10 mg); D&amp;C yellow #10 (20 mg); FD&amp;C blue #1, FD&amp;C red #40 (30 mg); FD&amp;C blue #1, FD&amp;C red #40 (50 mg); FD&amp;C blue #1, FD&amp;C red #40 (60 mg); FD&amp;C red #40, FD&amp;C yellow #6 (80 mg); FD&amp;C yellow #10, FD&amp;C blue #1 (100 mg). The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C 17H 19NO 3) 2∙H 2SO 4∙5H 2O and its molecular weight is 758.85. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1,000 parts of alcohol but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pK bis 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-229-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (10544-229-30)</PackageDescription>
    <NDC11Code>10544-0229-30</NDC11Code>
    <ProductNDC>10544-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levothyroxine Sodium</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120213</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021210</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.</IndicationAndUsage>
    <Description>Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T 4) sodium]. Synthetic T 4 is identical to that produced in the human thyroid gland. Levothyroxine (T 4) sodium has an empirical formula of C 15H 10I 4N NaO 4  H 2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:.</Description>
  </NDC>
  <NDC>
    <NDCCode>11822-0229-1</NDCCode>
    <PackageDescription>70 LOZENGE in 1 BAG (11822-0229-1) </PackageDescription>
    <NDC11Code>11822-0229-01</NDC11Code>
    <ProductNDC>11822-0229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sugar Free Menthol Flavor Cough Drop</ProprietaryName>
    <NonProprietaryName>Sugar Free Menthol Flavor Cough Drop</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240822</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Rite Aid Corporation</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>5.4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. temporarily relieves: 1 cough due to a cold, 2 occasional minor irritation, pain, sore mouth, and sore throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>14783-229-01</NDCCode>
    <PackageDescription>30 g in 1 TUBE (14783-229-01) </PackageDescription>
    <NDC11Code>14783-0229-01</NDC11Code>
    <ProductNDC>14783-229</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Claire 3</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201112</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2.44; 6.5; 1.57</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 doctorif rash occurs. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-229-01</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16714-229-01) </PackageDescription>
    <NDC11Code>16714-0229-01</NDC11Code>
    <ProductNDC>16714-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210722</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090132</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha 1-blocking activity. It is (2 RS)-1-(9 H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure:. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C 24H 26N 2O 4H 3PO 41/2 H 2O. Carvedilol phosphate extended-release capsules are available for once-a-day administration as extended-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate controlled-release minitablets that are coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate, methacrylic acid methyl methacrylate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, talc and triethyl citrate. The capsule shell contains gelatin and titanium dioxide. The 20 mg capsule shell also contains FD&amp;C blue #1, FD&amp;C yellow #5 and FD&amp;C yellow #6. The 40 mg capsule shell also contains D&amp;C yellow #10 and FD&amp;C yellow #6. The 80 mg capsule shell also contains D&amp;C yellow #10 and FD&amp;C blue #1. The imprinting ink for the 10 mg, 40 mg and 80 mg contains D&amp;C yellow #10 lake, FD&amp;C blue #1, FD&amp;C blue #2, FD&amp;C red #40, iron oxide black, propylene glycol and shellac glaze. The imprinting ink for the 20 mg contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-229-03</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (16729-229-03)  / 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>16729-0229-03</NDC11Code>
    <ProductNDC>16729-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pemetrexed</ProprietaryName>
    <NonProprietaryName>Pemetrexed</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203485</ApplicationNumber>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>PEMETREXED DISODIUM HEMIPENTAHYDRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/4mL</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pemetrexed for injection is a folate analog metabolic inhibitor indicated: 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. ( 1.1) , 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1) , 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1) , 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1) Limitations of Use:Pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. ( 1.1) , 5 initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. ( 1.2) .</IndicationAndUsage>
    <Description>Pemetrexed for injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium hemipentahydrate, has the chemical name N-{4-[2-(2-amino-4-oxo-4,7-dihydro-1 H-pyrrolo[2,3- d]pyrimidin-5-yl)ethyl]phenyl] carbonyl}-L-glutamic acid disodium, hemipentahydrate with a molecular formula of C 20H 19N 5Na 2O 62.5H 2O and a molecular weight of 516.41. The structural formula is as follows:. Pemetrexed for injection, USP is a sterile white to either light yellow or greenish yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of pemetrexed for injection, USP contains 100 mg pemetrexed (equivalent to 120.8 mg pemetrexed disodium hemipentahydrate) and 106 mg mannitol. Each 500-mg vial of pemetrexed for injection, USP contains 500 mg pemetrexed (equivalent to 604 mg pemetrexed disodium hemipentahydrate) and 500 mg mannitol. Each 1-gram vial of pemetrexed for injection, USP contains 1 gram pemetrexed (equivalent to 1.208 gram pemetrexed disodium hemipentahydrate) and 1 gram mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-229-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (21695-229-60)</PackageDescription>
    <NDC11Code>21695-0229-60</NDC11Code>
    <ProductNDC>21695-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090127</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA078525</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>LAMOTRIGINE is an antiepileptic drug (AED) indicated for. Epilepsy—adjunctive therapy in patients ≥2 years of age: (1.1): 1 partial seizures., 2 generalized seizures of Lennox-Gastaut syndrome.</IndicationAndUsage>
    <Description>LAMOTRIGINE (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Tablets are supplied for oral administration as 25 mg (white), 100 mg (light peach), 150 mg (cream), and 200 mg (light blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: croscarmellose sodium, crospovidone, FD&amp;C Blue #2 Aluminum Lake (200 mg strength only), FD&amp;C Yellow No. 6 Lake (100 mg strength only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and yellow iron oxide (150 mg strength only).</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-229-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (23155-229-01) </PackageDescription>
    <NDC11Code>23155-0229-01</NDC11Code>
    <ProductNDC>23155-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074889</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:  Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules, USP are a formulation for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients, microcrystalline cellulose, povidone, sodium starch glycolate, pregelatinized starch and magnesium stearate. The capsule shell consists of gelatin, FD&amp;C Blue No. 2 and titanium dioxide. Printed with edible black ink with the following components: shellac, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-229-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (23155-229-05) </PackageDescription>
    <NDC11Code>23155-0229-05</NDC11Code>
    <ProductNDC>23155-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074889</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:  Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules, USP are a formulation for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients, microcrystalline cellulose, povidone, sodium starch glycolate, pregelatinized starch and magnesium stearate. The capsule shell consists of gelatin, FD&amp;C Blue No. 2 and titanium dioxide. Printed with edible black ink with the following components: shellac, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-229-05</NDCCode>
    <PackageDescription>5 VIAL in 1 CARTON (25021-229-05)  / 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0229-05</NDC11Code>
    <ProductNDC>25021-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cytarabine</ProprietaryName>
    <NonProprietaryName>Cytarabine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211937</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>CYTARABINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.</IndicationAndUsage>
    <Description>Cytarabine Injection, an antineoplastic, is a sterile solution of cytarabine for intravenous, intrathecal or subcutaneous administration. Each mL contains 20 mg Cytarabine (20 mg per mL) in a single dose vial (100 mg per 5 mL). Cytarabine Injection 100 mg per 5 mL is a sterile solution for intravenous, intrathecal or subcutaneous administration. Each mL contains 20 mg Cytarabine, USP, and the following inactive ingredients: sodium chloride 6.8 mg and Water for Injection q.s. When necessary the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a pH of 7.4. Each vial contains approximately 0.58 mEq sodium. Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. The structural formula is:. Cytarabine is an odorless, white to off-white crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform.</Description>
  </NDC>
  <NDC>
    <NDCCode>27241-229-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-229-01) </PackageDescription>
    <NDC11Code>27241-0229-01</NDC11Code>
    <ProductNDC>27241-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215663</ApplicationNumber>
    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
    <Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in Dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules contain the following inactive ingredients: sugar spheres, hypromellose, ethyl cellulose, ammonium hydroxide, triglyceride, oleic acid, polyethylene glycol, povidone, glyceryl dibehenate, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum. The capsule shell contains: gelatin, titanium dioxide, (25 mg, 50 mg, 100 mg and 200 mg), sodium lauryl sulfate (100 mg). FD &amp; C Blue 1, FD &amp; C Red 3, FD &amp; C Red 40 (25 mg, 100 mg and 200 mg), iron oxide yellow, iron oxide red (50 mg). For 25 mg, 50 mg, 100 mg (body &amp; cap) and 200 mg (body only) strengths, imprinting black ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. For 200 mg (cap only) strength, imprinting white ink contains: shellac, ethanol, isopropyl alcohol, n-butanol, propylene glycol, ammonia solution, potassium hydroxide and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>27241-229-30</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-229-30) </PackageDescription>
    <NDC11Code>27241-0229-30</NDC11Code>
    <ProductNDC>27241-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230815</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215663</ApplicationNumber>
    <LabelerName>Ajanta Pharma USA Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
    <Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in Dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules contain the following inactive ingredients: sugar spheres, hypromellose, ethyl cellulose, ammonium hydroxide, triglyceride, oleic acid, polyethylene glycol, povidone, glyceryl dibehenate, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum. The capsule shell contains: gelatin, titanium dioxide, (25 mg, 50 mg, 100 mg and 200 mg), sodium lauryl sulfate (100 mg). FD &amp; C Blue 1, FD &amp; C Red 3, FD &amp; C Red 40 (25 mg, 100 mg and 200 mg), iron oxide yellow, iron oxide red (50 mg). For 25 mg, 50 mg, 100 mg (body &amp; cap) and 200 mg (body only) strengths, imprinting black ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. For 200 mg (cap only) strength, imprinting white ink contains: shellac, ethanol, isopropyl alcohol, n-butanol, propylene glycol, ammonia solution, potassium hydroxide and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-229-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-229-01) </PackageDescription>
    <NDC11Code>31722-0229-01</NDC11Code>
    <ProductNDC>31722-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215523</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2021-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d­-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: Polyethylene glycol, sugar spheres (which contain corn starch and sucrose), ammonio methacrylate copolymer, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, talc, acetone, isopropyl alcohol, titanium dioxide, gelatin and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, and strong ammonia solution. Additional ink ingredients in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 40 mg strengths are black iron oxide and potassium hydroxide, 35 mg strength is red iron oxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: FD&amp;C blue No. 1, FD&amp;C red No. 3, FD&amp;C yellow No. 6 and D&amp;C yellow No. 10, 2 10 mg: contains no colorants, 3 15 mg: FD&amp;C yellow No. 6 and D&amp;C yellow No. 10, 4 20 mg: FD&amp;C red No. 40, FD&amp;C blue No. 1 and D&amp;C yellow No. 10, 5 25 mg: FD&amp;C yellow No. 6 and D&amp;C yellow No. 10, 6 30 mg: contains no colorants, 7 35 mg: Iron oxide yellow, 8 40 mg: FD&amp;C yellow No. 6 and D&amp;C yellow No. 10.</Description>
  </NDC>
  <NDC>
    <NDCCode>42023-229-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (42023-229-10)  / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>42023-0229-10</NDC11Code>
    <ProductNDC>42023-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Micafungin</ProprietaryName>
    <NonProprietaryName>Micafungin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212156</ApplicationNumber>
    <LabelerName>Par Health USA, LLC</LabelerName>
    <SubstanceName>MICAFUNGIN SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Micafungin for Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 3 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].</IndicationAndUsage>
    <Description>Micafungin for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1, 3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) and 200 mg sucrose or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium) and 400 mg sucrose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2.3)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 4.5 to 7.0. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy)phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.</Description>
  </NDC>
  <NDC>
    <NDCCode>42254-229-22</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (42254-229-22)  &gt; 22 g in 1 TUBE</PackageDescription>
    <NDC11Code>42254-0229-22</NDC11Code>
    <ProductNDC>42254-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mupirocin</ProprietaryName>
    <NonProprietaryName>Mupirocin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065123</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <SubstanceName>MUPIROCIN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes.</IndicationAndUsage>
    <Description>Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C26H44O9 and the molecular weight is 500.62. The chemical structure is.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-229-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42291-229-90)</PackageDescription>
    <NDC11Code>42291-0229-90</NDC11Code>
    <ProductNDC>42291-229</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desloratadine</ProprietaryName>
    <NonProprietaryName>Desloratadine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078355</ApplicationNumber>
    <LabelerName>AvKARE, Inc.</LabelerName>
    <SubstanceName>DESLORATADINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-15</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>