{
"NDC": [
{
"NDCCode": "49288-0332-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0332-1)",
"NDC11Code": "49288-0332-01",
"ProductNDC": "49288-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oak Mixture",
"NonProprietaryName": "Oak Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN",
"StrengthNumber": ".0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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.",
"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."
},
{
"NDCCode": "49288-0332-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0332-2)",
"NDC11Code": "49288-0332-02",
"ProductNDC": "49288-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oak Mixture",
"NonProprietaryName": "Oak Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN",
"StrengthNumber": ".0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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.",
"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."
},
{
"NDCCode": "49288-0332-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0332-3)",
"NDC11Code": "49288-0332-03",
"ProductNDC": "49288-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oak Mixture",
"NonProprietaryName": "Oak Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN",
"StrengthNumber": ".0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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.",
"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."
},
{
"NDCCode": "49288-0332-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0332-4)",
"NDC11Code": "49288-0332-04",
"ProductNDC": "49288-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oak Mixture",
"NonProprietaryName": "Oak Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN",
"StrengthNumber": ".0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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.",
"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."
},
{
"NDCCode": "49288-0332-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0332-5)",
"NDC11Code": "49288-0332-05",
"ProductNDC": "49288-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oak Mixture",
"NonProprietaryName": "Oak Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN",
"StrengthNumber": ".0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"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.",
"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."
},
{
"NDCCode": "0065-0332-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (0065-0332-08) > 8 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "00065-0332-08",
"ProductNDC": "0065-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Patanase",
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20080428",
"EndMarketingDate": "20220831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021861",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080428",
"EndMarketingDatePackage": "20220831",
"SamplePackage": "N"
},
{
"NDCCode": "0065-0332-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0065-0332-30) > 240 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "00065-0332-30",
"ProductNDC": "0065-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Patanase",
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20080428",
"EndMarketingDate": "20220831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021861",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080428",
"EndMarketingDatePackage": "20220831",
"SamplePackage": "N"
},
{
"NDCCode": "0069-0600-01",
"PackageDescription": "1 KIT in 1 CARTON (0069-0600-01) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) ",
"NDC11Code": "00069-0600-01",
"ProductNDC": "0069-0600",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Penbraya",
"NonProprietaryName": "Meningococcal Groups A, B, C, W, And Y Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20231127",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125770",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.",
"Description": "PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives."
},
{
"NDCCode": "0069-0600-05",
"PackageDescription": "5 KIT in 1 CARTON (0069-0600-05) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) ",
"NDC11Code": "00069-0600-05",
"ProductNDC": "0069-0600",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Penbraya",
"NonProprietaryName": "Meningococcal Groups A, B, C, W, And Y Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20231127",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125770",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.",
"Description": "PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives."
},
{
"NDCCode": "0069-0600-10",
"PackageDescription": "10 KIT in 1 CARTON (0069-0600-10) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) ",
"NDC11Code": "00069-0600-10",
"ProductNDC": "0069-0600",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Penbraya",
"NonProprietaryName": "Meningococcal Groups A, B, C, W, And Y Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20231127",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125770",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.",
"Description": "PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives."
},
{
"NDCCode": "0113-0332-40",
"PackageDescription": "355 mL in 1 BOTTLE (0113-0332-40) ",
"NDC11Code": "00113-0332-40",
"ProductNDC": "0113-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Milk Of Magnesia",
"ProprietaryNameSuffix": "Stimulant Free",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19910615",
"EndMarketingDate": "20221130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "L Perrigo Company",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19910615",
"EndMarketingDatePackage": "20221130",
"SamplePackage": "N"
},
{
"NDCCode": "0168-0332-15",
"PackageDescription": "15 g in 1 TUBE (0168-0332-15) ",
"NDC11Code": "00168-0332-15",
"ProductNDC": "0168-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076451",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040514",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.",
"Description": "Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6α,11β,16α,17α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate USP has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative."
},
{
"NDCCode": "0168-0332-30",
"PackageDescription": "30 g in 1 TUBE (0168-0332-30) ",
"NDC11Code": "00168-0332-30",
"ProductNDC": "0168-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076451",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040514",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.",
"Description": "Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6α,11β,16α,17α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate USP has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative."
},
{
"NDCCode": "0168-0332-60",
"PackageDescription": "60 g in 1 TUBE (0168-0332-60) ",
"NDC11Code": "00168-0332-60",
"ProductNDC": "0168-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076451",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040514",
"SamplePackage": "N",
"IndicationAndUsage": "Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.",
"Description": "Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6α,11β,16α,17α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate USP has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative."
},
{
"NDCCode": "0360-0332-01",
"PackageDescription": "1 g in 1 BOTTLE, PLASTIC (0360-0332-01) ",
"NDC11Code": "00360-0332-01",
"ProductNDC": "0360-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ruta Graveolens",
"NonProprietaryName": "Ruta Grav",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "19970217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "STANDARD HOMEOPATHIC COMPANY",
"SubstanceName": "RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19970217",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0332-35",
"PackageDescription": "769 mL in 1 BOTTLE (0363-0332-35) ",
"NDC11Code": "00363-0332-35",
"ProductNDC": "0363-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Milk Of Magnesia",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19951110",
"EndMarketingDate": "20210131",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Walgreen Company",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19951110",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0332-40",
"PackageDescription": "355 mL in 1 BOTTLE (0363-0332-40) ",
"NDC11Code": "00363-0332-40",
"ProductNDC": "0363-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Milk Of Magnesia",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19951110",
"EndMarketingDate": "20210131",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Walgreen Company",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19951201",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
},
{
"NDCCode": "0409-0332-20",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0332-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0332-20",
"ProductNDC": "0409-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bleomycin",
"NonProprietaryName": "Bleomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20150425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065031",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BLEOMYCIN SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "[USP'U]/1",
"Pharm_Classes": "Cytoprotective Agent [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180425",
"SamplePackage": "N",
"IndicationAndUsage": "Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents. Squamous Cell Carcinoma. Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is poorer in patients with previously irradiated head and neck cancer. Lymphomas. Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma. Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin has also been shown to be useful in the management of:. Malignant Pleural Effusion Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.",
"Description": "Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It is freely soluble in water. It is available as a lyophilized powder for intramuscular, intravenous or subcutaneous injection. Each vial contains sterile bleomycin sulphate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or Sodium hydroxide used, if necessary to adjust the pH. Bleomycins are a group of related basic glycopeptides which differ in the terminal amine substituent of the common structural unit, bleomycin acid. The main components of Bleomycin for Injection are bleomycins A2 and B2. Chemically, bleomycin A2 is N1-[3-(dimethylsulfonio)propyl]-bleomycinamide and bleomycin B2 is N1-[4-(aminoiminomethyl)amino]butyl]-bleomycinamide. The molecular formula of bleomycin A2 is C55H84N17O21S3 and a calculated molecular weight of 1414. The molecular formula of bleomycin B2 is C55H84N20O21S2 and a calculated molecular weight of 1425. The structural formula of bleomycins A2 and B2 are shown below. Note: A unit of bleomycin is equal to the formerly used milligram activity. The term milligram activity is a misnomer and was changed to units to be more precise."
},
{
"NDCCode": "0615-0332-39",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (0615-0332-39)",
"NDC11Code": "00615-0332-39",
"ProductNDC": "0615-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19811214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086183",
"LabelerName": "NCS HealthCare of KY, Inc dba Vangard Labs",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11014-0332-1",
"PackageDescription": "1 BAG in 1 CONTAINER (11014-0332-1) / 10000 CAPSULE in 1 BAG",
"NDC11Code": "11014-0332-01",
"ProductNDC": "11014-0332",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20220513",
"EndMarketingDate": "20250331",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "13-MAY-22",
"EndMarketingDatePackage": "31-MAR-25"
},
{
"NDCCode": "15631-0332-0",
"PackageDescription": "100 PELLET in 1 PACKAGE (15631-0332-0) ",
"NDC11Code": "15631-0332-00",
"ProductNDC": "15631-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "Petroleum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "KEROSENE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0332-1",
"PackageDescription": "200 PELLET in 1 PACKAGE (15631-0332-1) ",
"NDC11Code": "15631-0332-01",
"ProductNDC": "15631-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "Petroleum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "KEROSENE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
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},
{
"NDCCode": "15631-0332-2",
"PackageDescription": "400 PELLET in 1 PACKAGE (15631-0332-2) ",
"NDC11Code": "15631-0332-02",
"ProductNDC": "15631-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "Petroleum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "KEROSENE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0332-3",
"PackageDescription": "750 PELLET in 1 PACKAGE (15631-0332-3) ",
"NDC11Code": "15631-0332-03",
"ProductNDC": "15631-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "Petroleum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "KEROSENE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0332-4",
"PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0332-4) ",
"NDC11Code": "15631-0332-04",
"ProductNDC": "15631-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "Petroleum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "KEROSENE",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
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},
{
"NDCCode": "15631-0332-5",
"PackageDescription": "12500 PELLET in 1 PACKAGE (15631-0332-5) ",
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"ProductNDC": "15631-0332",
"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Petroleum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
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"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "KEROSENE",
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"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0332-6",
"PackageDescription": "500 PELLET in 1 PACKAGE (15631-0332-6) ",
"NDC11Code": "15631-0332-06",
"ProductNDC": "15631-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "Petroleum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "KEROSENE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210823",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0332-7",
"PackageDescription": "1000 PELLET in 1 PACKAGE (15631-0332-7) ",
"NDC11Code": "15631-0332-07",
"ProductNDC": "15631-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "Petroleum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "KEROSENE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210823",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "24555-0332-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (24555-0332-3) ",
"NDC11Code": "24555-0332-03",
"ProductNDC": "24555-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077321",
"LabelerName": "Correct Rx Pharmacy Services, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablets USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1) , 2 Adjunct therapy for heart failure ( 1.2) , 3 Treatment of Acute Myocardial Infarction ( 1.3) .",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn)."
},
{
"NDCCode": "37662-0332-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-0332-1) ",
"NDC11Code": "37662-0332-01",
"ProductNDC": "37662-0332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cinnamomum",
"NonProprietaryName": "Cinnamomum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220603",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CINNAMON",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220603",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49288-0332-1</NDCCode>
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<ProductNDC>49288-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oak Mixture</ProprietaryName>
<NonProprietaryName>Oak Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>.0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0332-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0332-2)</PackageDescription>
<NDC11Code>49288-0332-02</NDC11Code>
<ProductNDC>49288-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oak Mixture</ProprietaryName>
<NonProprietaryName>Oak Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>.0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0332-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0332-3)</PackageDescription>
<NDC11Code>49288-0332-03</NDC11Code>
<ProductNDC>49288-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oak Mixture</ProprietaryName>
<NonProprietaryName>Oak Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>.0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0332-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0332-4)</PackageDescription>
<NDC11Code>49288-0332-04</NDC11Code>
<ProductNDC>49288-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oak Mixture</ProprietaryName>
<NonProprietaryName>Oak Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>.0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0332-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0332-5)</PackageDescription>
<NDC11Code>49288-0332-05</NDC11Code>
<ProductNDC>49288-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oak Mixture</ProprietaryName>
<NonProprietaryName>Oak Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>.0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>0065-0332-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0065-0332-08) > 8 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00065-0332-08</NDC11Code>
<ProductNDC>0065-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Patanase</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20080428</StartMarketingDate>
<EndMarketingDate>20220831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021861</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080428</StartMarketingDatePackage>
<EndMarketingDatePackage>20220831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0065-0332-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0065-0332-30) > 240 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00065-0332-30</NDC11Code>
<ProductNDC>0065-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Patanase</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20080428</StartMarketingDate>
<EndMarketingDate>20220831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021861</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080428</StartMarketingDatePackage>
<EndMarketingDatePackage>20220831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0069-0600-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0069-0600-01) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) </PackageDescription>
<NDC11Code>00069-0600-01</NDC11Code>
<ProductNDC>0069-0600</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Penbraya</ProprietaryName>
<NonProprietaryName>Meningococcal Groups A, B, C, W, And Y Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231127</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125770</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0069-0600-05</NDCCode>
<PackageDescription>5 KIT in 1 CARTON (0069-0600-05) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) </PackageDescription>
<NDC11Code>00069-0600-05</NDC11Code>
<ProductNDC>0069-0600</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Penbraya</ProprietaryName>
<NonProprietaryName>Meningococcal Groups A, B, C, W, And Y Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231127</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125770</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0069-0600-10</NDCCode>
<PackageDescription>10 KIT in 1 CARTON (0069-0600-10) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) </PackageDescription>
<NDC11Code>00069-0600-10</NDC11Code>
<ProductNDC>0069-0600</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Penbraya</ProprietaryName>
<NonProprietaryName>Meningococcal Groups A, B, C, W, And Y Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231127</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125770</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0113-0332-40</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (0113-0332-40) </PackageDescription>
<NDC11Code>00113-0332-40</NDC11Code>
<ProductNDC>0113-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Milk Of Magnesia</ProprietaryName>
<ProprietaryNameSuffix>Stimulant Free</ProprietaryNameSuffix>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910615</StartMarketingDate>
<EndMarketingDate>20221130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>L Perrigo Company</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19910615</StartMarketingDatePackage>
<EndMarketingDatePackage>20221130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0168-0332-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0332-15) </PackageDescription>
<NDC11Code>00168-0332-15</NDC11Code>
<ProductNDC>0168-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076451</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.</IndicationAndUsage>
<Description>Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6α,11β,16α,17α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate USP has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative.</Description>
</NDC>
<NDC>
<NDCCode>0168-0332-30</NDCCode>
<PackageDescription>30 g in 1 TUBE (0168-0332-30) </PackageDescription>
<NDC11Code>00168-0332-30</NDC11Code>
<ProductNDC>0168-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076451</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.</IndicationAndUsage>
<Description>Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6α,11β,16α,17α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate USP has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative.</Description>
</NDC>
<NDC>
<NDCCode>0168-0332-60</NDCCode>
<PackageDescription>60 g in 1 TUBE (0168-0332-60) </PackageDescription>
<NDC11Code>00168-0332-60</NDC11Code>
<ProductNDC>0168-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076451</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.</IndicationAndUsage>
<Description>Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6α,11β,16α,17α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:. Fluticasone propionate USP has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative.</Description>
</NDC>
<NDC>
<NDCCode>0360-0332-01</NDCCode>
<PackageDescription>1 g in 1 BOTTLE, PLASTIC (0360-0332-01) </PackageDescription>
<NDC11Code>00360-0332-01</NDC11Code>
<ProductNDC>0360-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ruta Graveolens</ProprietaryName>
<NonProprietaryName>Ruta Grav</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19970217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>STANDARD HOMEOPATHIC COMPANY</LabelerName>
<SubstanceName>RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0332-35</NDCCode>
<PackageDescription>769 mL in 1 BOTTLE (0363-0332-35) </PackageDescription>
<NDC11Code>00363-0332-35</NDC11Code>
<ProductNDC>0363-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Milk Of Magnesia</ProprietaryName>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951110</StartMarketingDate>
<EndMarketingDate>20210131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19951110</StartMarketingDatePackage>
<EndMarketingDatePackage>20210131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0332-40</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (0363-0332-40) </PackageDescription>
<NDC11Code>00363-0332-40</NDC11Code>
<ProductNDC>0363-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Milk Of Magnesia</ProprietaryName>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951110</StartMarketingDate>
<EndMarketingDate>20210131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19951201</StartMarketingDatePackage>
<EndMarketingDatePackage>20210131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-0332-20</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0332-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0332-20</NDC11Code>
<ProductNDC>0409-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bleomycin</ProprietaryName>
<NonProprietaryName>Bleomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065031</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BLEOMYCIN SULFATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>[USP'U]/1</StrengthUnit>
<Pharm_Classes>Cytoprotective Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents. Squamous Cell Carcinoma. Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is poorer in patients with previously irradiated head and neck cancer. Lymphomas. Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma. Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin has also been shown to be useful in the management of:. Malignant Pleural Effusion Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.</IndicationAndUsage>
<Description>Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It is freely soluble in water. It is available as a lyophilized powder for intramuscular, intravenous or subcutaneous injection. Each vial contains sterile bleomycin sulphate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or Sodium hydroxide used, if necessary to adjust the pH. Bleomycins are a group of related basic glycopeptides which differ in the terminal amine substituent of the common structural unit, bleomycin acid. The main components of Bleomycin for Injection are bleomycins A2 and B2. Chemically, bleomycin A2 is N1-[3-(dimethylsulfonio)propyl]-bleomycinamide and bleomycin B2 is N1-[4-(aminoiminomethyl)amino]butyl]-bleomycinamide. The molecular formula of bleomycin A2 is C55H84N17O21S3 and a calculated molecular weight of 1414. The molecular formula of bleomycin B2 is C55H84N20O21S2 and a calculated molecular weight of 1425. The structural formula of bleomycins A2 and B2 are shown below. Note: A unit of bleomycin is equal to the formerly used milligram activity. The term milligram activity is a misnomer and was changed to units to be more precise.</Description>
</NDC>
<NDC>
<NDCCode>0615-0332-39</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (0615-0332-39)</PackageDescription>
<NDC11Code>00615-0332-39</NDC11Code>
<ProductNDC>0615-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086183</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11014-0332-1</NDCCode>
<PackageDescription>1 BAG in 1 CONTAINER (11014-0332-1) / 10000 CAPSULE in 1 BAG</PackageDescription>
<NDC11Code>11014-0332-01</NDC11Code>
<ProductNDC>11014-0332</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20220513</StartMarketingDate>
<EndMarketingDate>20250331</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>13-MAY-22</StartMarketingDatePackage>
<EndMarketingDatePackage>31-MAR-25</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>15631-0332-0</NDCCode>
<PackageDescription>100 PELLET in 1 PACKAGE (15631-0332-0) </PackageDescription>
<NDC11Code>15631-0332-00</NDC11Code>
<ProductNDC>15631-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>Petroleum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>KEROSENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-10-05</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>15631-0332-1</NDCCode>
<PackageDescription>200 PELLET in 1 PACKAGE (15631-0332-1) </PackageDescription>
<NDC11Code>15631-0332-01</NDC11Code>
<ProductNDC>15631-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>Petroleum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>KEROSENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-10-05</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>15631-0332-2</NDCCode>
<PackageDescription>400 PELLET in 1 PACKAGE (15631-0332-2) </PackageDescription>
<NDC11Code>15631-0332-02</NDC11Code>
<ProductNDC>15631-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>Petroleum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>KEROSENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-10-05</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>15631-0332-3</NDCCode>
<PackageDescription>750 PELLET in 1 PACKAGE (15631-0332-3) </PackageDescription>
<NDC11Code>15631-0332-03</NDC11Code>
<ProductNDC>15631-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>Petroleum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>KEROSENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-10-05</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>15631-0332-4</NDCCode>
<PackageDescription>2500 PELLET in 1 PACKAGE (15631-0332-4) </PackageDescription>
<NDC11Code>15631-0332-04</NDC11Code>
<ProductNDC>15631-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>Petroleum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>KEROSENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-10-05</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>15631-0332-5</NDCCode>
<PackageDescription>12500 PELLET in 1 PACKAGE (15631-0332-5) </PackageDescription>
<NDC11Code>15631-0332-05</NDC11Code>
<ProductNDC>15631-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>Petroleum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>KEROSENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-10-05</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>15631-0332-6</NDCCode>
<PackageDescription>500 PELLET in 1 PACKAGE (15631-0332-6) </PackageDescription>
<NDC11Code>15631-0332-06</NDC11Code>
<ProductNDC>15631-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>Petroleum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>KEROSENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0332-7</NDCCode>
<PackageDescription>1000 PELLET in 1 PACKAGE (15631-0332-7) </PackageDescription>
<NDC11Code>15631-0332-07</NDC11Code>
<ProductNDC>15631-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>Petroleum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>KEROSENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24555-0332-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (24555-0332-3) </PackageDescription>
<NDC11Code>24555-0332-03</NDC11Code>
<ProductNDC>24555-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077321</ApplicationNumber>
<LabelerName>Correct Rx Pharmacy Services, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablets USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1) , 2 Adjunct therapy for heart failure ( 1.2) , 3 Treatment of Acute Myocardial Infarction ( 1.3) .</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn).</Description>
</NDC>
<NDC>
<NDCCode>37662-0332-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-0332-1) </PackageDescription>
<NDC11Code>37662-0332-01</NDC11Code>
<ProductNDC>37662-0332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cinnamomum</ProprietaryName>
<NonProprietaryName>Cinnamomum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220603</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CINNAMON</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>