RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "49288-0036-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0036-4)",
      "NDC11Code": "49288-0036-04",
      "ProductNDC": "49288-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "B Mold Mixture",
      "NonProprietaryName": "B Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII",
      "StrengthNumber": ".0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [CS],Allergens [CS],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0036-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0036-1)",
      "NDC11Code": "49288-0036-01",
      "ProductNDC": "49288-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "B Mold Mixture",
      "NonProprietaryName": "B Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII",
      "StrengthNumber": ".0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [CS],Allergens [CS],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0036-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0036-2)",
      "NDC11Code": "49288-0036-02",
      "ProductNDC": "49288-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "B Mold Mixture",
      "NonProprietaryName": "B Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII",
      "StrengthNumber": ".0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [CS],Allergens [CS],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0036-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0036-3)",
      "NDC11Code": "49288-0036-03",
      "ProductNDC": "49288-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "B Mold Mixture",
      "NonProprietaryName": "B Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII",
      "StrengthNumber": ".0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [CS],Allergens [CS],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0036-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0036-5)",
      "NDC11Code": "49288-0036-05",
      "ProductNDC": "49288-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "B Mold Mixture",
      "NonProprietaryName": "B Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII",
      "StrengthNumber": ".0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [CS],Allergens [CS],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "13630-0036-4",
      "PackageDescription": "177 mL in 1 CAN (13630-0036-4) ",
      "NDC11Code": "13630-0036-04",
      "ProductNDC": "13630-0036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Panama Jack",
      "ProprietaryNameSuffix": "Broad Spectrum Spf 70",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120221",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Prime Packaging, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "25.6; 106.8; 42.7; 23.5; 51.2",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20120221",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "15631-0036-4",
      "PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0036-4) ",
      "NDC11Code": "15631-0036-04",
      "ProductNDC": "15631-0036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antimonium Crudum",
      "NonProprietaryName": "Antimonium Crudum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150906",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "ANTIMONY TRISULFIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "22552-0036-4",
      "PackageDescription": "1 BAG in 1 CONTAINER (22552-0036-4)  / 100 g in 1 BAG",
      "NDC11Code": "22552-0036-04",
      "ProductNDC": "22552-0036",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Hydrocortisone Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130604",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Symbiotec Pharmalab Limited",
      "SubstanceName": "HYDROCORTISONE ACETATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-18",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "04-JUN-13"
    },
    {
      "NDCCode": "23319-0036-1",
      "PackageDescription": "1 TUBE in 1 CARTON (23319-0036-1)  > 4 g in 1 TUBE",
      "NDC11Code": "23319-0036-01",
      "ProductNDC": "23319-0036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Burdeo Night",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181115",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Yanbal USA, Inc.",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20181115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37662-0036-4",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0036-4) ",
      "NDC11Code": "37662-0036-04",
      "ProductNDC": "37662-0036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calcarea Arsenicica",
      "NonProprietaryName": "Calcarea Arsenicica",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220516",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CALCIUM ARSENATE",
      "StrengthNumber": "200",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-05-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220516",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43596-0036-2",
      "PackageDescription": "1 TUBE in 1 BOX (43596-0036-2)  > 4 g in 1 TUBE (43596-0036-1)",
      "NDC11Code": "43596-0036-02",
      "ProductNDC": "43596-0036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esika Pro Hd Longwear Long-lasting High-definition Color Spf 20",
      "ProprietaryNameSuffix": "Rojo Fiesta - Red",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170127",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": ".068",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "50090-0036-4",
      "PackageDescription": "6 TABLET in 1 BOTTLE (50090-0036-4)",
      "NDC11Code": "50090-0036-04",
      "ProductNDC": "50090-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine Hydrochloride",
      "NonProprietaryName": "Phenazopyridine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110201",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-08"
    },
    {
      "NDCCode": "54532-0036-4",
      "PackageDescription": "10 AMPULE in 1 CARTON (54532-0036-4)  > 2 mL in 1 AMPULE",
      "NDC11Code": "54532-0036-04",
      "ProductNDC": "54532-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hevert Calmvalera Comp.",
      "NonProprietaryName": "Black Cohosh, Anamirta Cocculus Seed, Cypripedium Parvifolum Root, Strychnos Ignatii Seed, Passiflora Incarnata Flowering Top, Platinum, Valerian, And Zinc Valerate Dihydrate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20160801",
      "EndMarketingDate": "20211231",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hevert Pharmaceuticals LLC",
      "SubstanceName": "BLACK COHOSH; ANAMIRTA COCCULUS SEED; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; VALERIAN; ZINC VALERATE DIHYDRATE",
      "StrengthNumber": "4; 4; 4; 6; 4; 10; 4; 8",
      "StrengthUnit": "[hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160801",
      "EndMarketingDatePackage": "20211231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67835-0036-4",
      "PackageDescription": "1 BAG in 1 DRUM (67835-0036-4)  / 10 kg in 1 BAG",
      "NDC11Code": "67835-0036-04",
      "ProductNDC": "67835-0036",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Deferasirox",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240612",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SMS Pharmaceuticals Limited",
      "SubstanceName": "DEFERASIROX",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-06-14",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "12-JUN-24"
    },
    {
      "NDCCode": "69117-0036-4",
      "PackageDescription": "500 TABLET in 1 BOTTLE (69117-0036-4) ",
      "NDC11Code": "69117-0036-04",
      "ProductNDC": "69117-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril",
      "NonProprietaryName": "Lisinopril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212041",
      "LabelerName": "Yiling Pharmaceutical, Inc.",
      "SubstanceName": "LISINOPRIL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for:  Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1)  Adjunct therapy for heart failure (1.2)  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 C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-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. Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate. Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide."
    },
    {
      "NDCCode": "69540-0036-4",
      "PackageDescription": "270 PATCH in 1 CANISTER (69540-0036-4)  / .13 g in 1 PATCH",
      "NDC11Code": "69540-0036-04",
      "ProductNDC": "69540-0036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clorox Hand Sanitizer",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210824",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Brand Buzz LLC",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".13",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210824",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizing to help reduce bacteria on the skin."
    },
    {
      "NDCCode": "71335-0036-4",
      "PackageDescription": "90 TABLET in 1 BOTTLE (71335-0036-4) ",
      "NDC11Code": "71335-0036-04",
      "ProductNDC": "71335-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glipizide",
      "NonProprietaryName": "Glipizide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110718",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074550",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "GLIPIZIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180419",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76370-0036-1",
      "PackageDescription": "4 BOTTLE in 1 BOX (76370-0036-1)  / 30 mL in 1 BOTTLE (76370-0036-0) ",
      "NDC11Code": "76370-0036-01",
      "ProductNDC": "76370-0036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vibemist Hydrating Hand Sanitizer Peppermint Lemon",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Tazza Brands East Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses Decreases bacteria on hands."
    },
    {
      "NDCCode": "79481-0036-4",
      "PackageDescription": "4 TABLET, FILM COATED in 1 BLISTER PACK (79481-0036-4) ",
      "NDC11Code": "79481-0036-04",
      "ProductNDC": "79481-0036",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Meijer, Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing."
    },
    {
      "NDCCode": "49288-0037-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0037-4)",
      "NDC11Code": "49288-0037-04",
      "ProductNDC": "49288-0037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "B Mold Mixture",
      "NonProprietaryName": "B Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII",
      "StrengthNumber": ".0018; .0018; .0018; .0018; .0018; .0018; .0018; .0036; .0018; .0018; .0018; .0018; .0018; .0018",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [CS],Allergens [CS],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0238-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0238-4)",
      "NDC11Code": "49288-0238-04",
      "ProductNDC": "49288-0238",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Number Fourteen Grass Mixture",
      "NonProprietaryName": "Number Fourteen Grass Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19970613",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POA COMPRESSA POLLEN; TYPHA LATIFOLIA POLLEN; BROMUS SECALINUS POLLEN; ZEA MAYS POLLEN; SECALE CEREALE POLLEN; TRITICUM AESTIVUM POLLEN; SORGHUM HALEPENSE POLLEN; ELYMUS REPENS POLLEN; PHALARIS ARUNDINACEA POLLEN; BROMUS INERMIS POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN; PASCOPYRUM SMITHII POLLEN",
      "StrengthNumber": ".0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; 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],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],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],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Cell-mediated Immunity [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [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],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],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": "49288-0612-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0612-4)",
      "NDC11Code": "49288-0612-04",
      "ProductNDC": "49288-0612",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Number Four Weed Mixture",
      "NonProprietaryName": "Number Four Weed Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ARTEMISIA CALIFORNICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ARTEMISIA VULGARIS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA DRACUNCULUS POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA AXILLARIS POLLEN; ARTEMISIA FRIGIDA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS TUBERCULATUS POLLEN; RUMEX CRISPUS POLLEN",
      "StrengthNumber": ".0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; 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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [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],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [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": "49288-0001-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0001-4)",
      "NDC11Code": "49288-0001-04",
      "ProductNDC": "49288-0001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0002-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0002-4)",
      "NDC11Code": "49288-0002-04",
      "ProductNDC": "49288-0002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0003-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0003-4)",
      "NDC11Code": "49288-0003-04",
      "ProductNDC": "49288-0003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".025",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0004-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0004-4)",
      "NDC11Code": "49288-0004-04",
      "ProductNDC": "49288-0004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0017; .0017; .0017; .0017; .0067; .0067; .0067; .0067; .0067; .0067; .0033; .0033; .0022; .0022; .0011; .0011; .0011; .0011; .0011; .0011; .0067; .0067; .0067; .0067; .0067; .0022",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0005-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0005-4)",
      "NDC11Code": "49288-0005-04",
      "ProductNDC": "49288-0005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0008; .0008; .0008; .0008; .0033; .0033; .0033; .0033; .0033; .0033; .0017; .0017; .0011; .0011; .0006; .0006; .0006; .0006; .0006; .0006; .0033; .0033; .0033; .0033; .0033; .0011",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0006-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0006-4)",
      "NDC11Code": "49288-0006-04",
      "ProductNDC": "49288-0006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0004; .0004; .0004; .0004; .0017; .0017; .0017; .0017; .0017; .0017; .0008; .0008; .0006; .0006; .0003; .0003; .0003; .0003; .0003; .0003; .0017; .0017; .0017; .0017; .0017; .0006",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [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": "49288-0007-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0007-4)",
      "NDC11Code": "49288-0007-04",
      "ProductNDC": "49288-0007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aspergillus Mixture",
      "NonProprietaryName": "Aspergillus Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS",
      "StrengthNumber": ".0025; .0025; .0025; .0025",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [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": "49288-0008-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0008-4)",
      "NDC11Code": "49288-0008-04",
      "ProductNDC": "49288-0008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aspergillus Mixture",
      "NonProprietaryName": "Aspergillus Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS",
      "StrengthNumber": ".0125; .0125; .0125; .0125",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [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."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"49288-0036-4","ProprietaryName":"B Mold Mixture","NonProprietaryName":"B Mold Mixture"},{"NDCCode":"49288-0036-1","ProprietaryName":"B Mold Mixture","NonProprietaryName":"B Mold Mixture"},{"NDCCode":"49288-0036-2","ProprietaryName":"B Mold Mixture","NonProprietaryName":"B Mold Mixture"},{"NDCCode":"49288-0036-3","ProprietaryName":"B Mold Mixture","NonProprietaryName":"B Mold Mixture"},{"NDCCode":"49288-0036-5","ProprietaryName":"B Mold Mixture","NonProprietaryName":"B Mold Mixture"},{"NDCCode":"13630-0036-4","ProprietaryName":"Panama Jack","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone"},{"NDCCode":"15631-0036-4","ProprietaryName":"Antimonium Crudum","NonProprietaryName":"Antimonium Crudum"},{"NDCCode":"22552-0036-4","NonProprietaryName":"Hydrocortisone Acetate"},{"NDCCode":"23319-0036-1","ProprietaryName":"Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Burdeo Night","NonProprietaryName":"Octinoxate"},{"NDCCode":"37662-0036-4","ProprietaryName":"Calcarea Arsenicica","NonProprietaryName":"Calcarea Arsenicica"},{"NDCCode":"43596-0036-2","ProprietaryName":"Esika Pro Hd Longwear Long-lasting High-definition Color Spf 20","NonProprietaryName":"Octinoxate"},{"NDCCode":"50090-0036-4","ProprietaryName":"Phenazopyridine Hydrochloride","NonProprietaryName":"Phenazopyridine"},{"NDCCode":"54532-0036-4","ProprietaryName":"Hevert Calmvalera Comp.","NonProprietaryName":"Black Cohosh, Anamirta Cocculus Seed, Cypripedium Parvifolum Root, Strychnos Ignatii Seed, Passiflora Incarnata Flowering Top, Platinum, Valerian, And Zinc Valerate Dihydrate"},{"NDCCode":"67835-0036-4","NonProprietaryName":"Deferasirox"},{"NDCCode":"69117-0036-4","ProprietaryName":"Lisinopril","NonProprietaryName":"Lisinopril"},{"NDCCode":"69540-0036-4","ProprietaryName":"Clorox Hand Sanitizer","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"71335-0036-4","ProprietaryName":"Glipizide","NonProprietaryName":"Glipizide"},{"NDCCode":"76370-0036-1","ProprietaryName":"Vibemist Hydrating Hand Sanitizer Peppermint Lemon","NonProprietaryName":"Alcohol"},{"NDCCode":"79481-0036-4","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"49288-0037-4","ProprietaryName":"B Mold Mixture","NonProprietaryName":"B Mold Mixture"},{"NDCCode":"49288-0238-4","ProprietaryName":"Number Fourteen Grass Mixture","NonProprietaryName":"Number Fourteen Grass Mixture"},{"NDCCode":"49288-0612-4","ProprietaryName":"Number Four Weed Mixture","NonProprietaryName":"Number Four Weed Mixture"},{"NDCCode":"49288-0001-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0002-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0003-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0004-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0005-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0006-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0007-4","ProprietaryName":"Aspergillus Mixture","NonProprietaryName":"Aspergillus Mixture"},{"NDCCode":"49288-0008-4","ProprietaryName":"Aspergillus Mixture","NonProprietaryName":"Aspergillus Mixture"}]}
                    

<NDCList><NDC><NDCCode>49288-0036-4</NDCCode><ProprietaryName>B Mold Mixture</ProprietaryName><NonProprietaryName>B Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0036-1</NDCCode><ProprietaryName>B Mold Mixture</ProprietaryName><NonProprietaryName>B Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0036-2</NDCCode><ProprietaryName>B Mold Mixture</ProprietaryName><NonProprietaryName>B Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0036-3</NDCCode><ProprietaryName>B Mold Mixture</ProprietaryName><NonProprietaryName>B Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0036-5</NDCCode><ProprietaryName>B Mold Mixture</ProprietaryName><NonProprietaryName>B Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>13630-0036-4</NDCCode><ProprietaryName>Panama Jack</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>15631-0036-4</NDCCode><ProprietaryName>Antimonium Crudum</ProprietaryName><NonProprietaryName>Antimonium Crudum</NonProprietaryName></NDC><NDC><NDCCode>22552-0036-4</NDCCode><NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>23319-0036-1</NDCCode><ProprietaryName>Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Burdeo Night</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>37662-0036-4</NDCCode><ProprietaryName>Calcarea Arsenicica</ProprietaryName><NonProprietaryName>Calcarea Arsenicica</NonProprietaryName></NDC><NDC><NDCCode>43596-0036-2</NDCCode><ProprietaryName>Esika Pro Hd Longwear Long-lasting High-definition Color Spf 20</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>50090-0036-4</NDCCode><ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName><NonProprietaryName>Phenazopyridine</NonProprietaryName></NDC><NDC><NDCCode>54532-0036-4</NDCCode><ProprietaryName>Hevert Calmvalera Comp.</ProprietaryName><NonProprietaryName>Black Cohosh, Anamirta Cocculus Seed, Cypripedium Parvifolum Root, Strychnos Ignatii Seed, Passiflora Incarnata Flowering Top, Platinum, Valerian, And Zinc Valerate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>67835-0036-4</NDCCode><NonProprietaryName>Deferasirox</NonProprietaryName></NDC><NDC><NDCCode>69117-0036-4</NDCCode><ProprietaryName>Lisinopril</ProprietaryName><NonProprietaryName>Lisinopril</NonProprietaryName></NDC><NDC><NDCCode>69540-0036-4</NDCCode><ProprietaryName>Clorox Hand Sanitizer</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>71335-0036-4</NDCCode><ProprietaryName>Glipizide</ProprietaryName><NonProprietaryName>Glipizide</NonProprietaryName></NDC><NDC><NDCCode>76370-0036-1</NDCCode><ProprietaryName>Vibemist Hydrating Hand Sanitizer Peppermint Lemon</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>79481-0036-4</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49288-0037-4</NDCCode><ProprietaryName>B Mold Mixture</ProprietaryName><NonProprietaryName>B Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0238-4</NDCCode><ProprietaryName>Number Fourteen Grass Mixture</ProprietaryName><NonProprietaryName>Number Fourteen Grass Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0612-4</NDCCode><ProprietaryName>Number Four Weed Mixture</ProprietaryName><NonProprietaryName>Number Four Weed Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0001-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0002-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0003-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0004-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0005-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0006-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0007-4</NDCCode><ProprietaryName>Aspergillus Mixture</ProprietaryName><NonProprietaryName>Aspergillus Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0008-4</NDCCode><ProprietaryName>Aspergillus Mixture</ProprietaryName><NonProprietaryName>Aspergillus Mixture</NonProprietaryName></NDC></NDCList>