RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "49288-0056-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0056-3)",
      "NDC11Code": "49288-0056-03",
      "ProductNDC": "49288-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Birch Mixture",
      "NonProprietaryName": "Birch Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN",
      "StrengthNumber": ".0083; .0083; .0083; .0083; .0083; .0083",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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": "49288-0056-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0056-1)",
      "NDC11Code": "49288-0056-01",
      "ProductNDC": "49288-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Birch Mixture",
      "NonProprietaryName": "Birch Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN",
      "StrengthNumber": ".0083; .0083; .0083; .0083; .0083; .0083",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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": "49288-0056-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0056-2)",
      "NDC11Code": "49288-0056-02",
      "ProductNDC": "49288-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Birch Mixture",
      "NonProprietaryName": "Birch Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN",
      "StrengthNumber": ".0083; .0083; .0083; .0083; .0083; .0083",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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": "49288-0056-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0056-4)",
      "NDC11Code": "49288-0056-04",
      "ProductNDC": "49288-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Birch Mixture",
      "NonProprietaryName": "Birch Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN",
      "StrengthNumber": ".0083; .0083; .0083; .0083; .0083; .0083",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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": "49288-0056-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0056-5)",
      "NDC11Code": "49288-0056-05",
      "ProductNDC": "49288-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Birch Mixture",
      "NonProprietaryName": "Birch Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN",
      "StrengthNumber": ".0083; .0083; .0083; .0083; .0083; .0083",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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": "15631-0056-3",
      "PackageDescription": "750 PELLET in 1 PACKAGE (15631-0056-3) ",
      "NDC11Code": "15631-0056-03",
      "ProductNDC": "15631-0056",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Artemisia Vulgaris",
      "NonProprietaryName": "Artemisia Vulgaris",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150911",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "ARTEMISIA VULGARIS ROOT",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "17337-0056-1",
      "PackageDescription": "8.3 kg in 1 DRUM (17337-0056-1) ",
      "NDC11Code": "17337-0056-01",
      "ProductNDC": "17337-0056",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Abiraterone Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20181108",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Olon SpA",
      "SubstanceName": "ABIRATERONE ACETATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-13",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "08-NOV-18"
    },
    {
      "NDCCode": "49817-0056-3",
      "PackageDescription": "200 mL in 1 BOTTLE (49817-0056-3)",
      "NDC11Code": "49817-0056-03",
      "ProductNDC": "49817-0056",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lingerie De Peau Invisible Skin-fusion Foundation With Sunscreen Broad Spectrum Spf 20 02 Beige Clair",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140410",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Guerlain S.A",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "30; 31.6",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "50090-0056-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE (50090-0056-3)",
      "NDC11Code": "50090-0056-03",
      "ProductNDC": "50090-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078558",
      "LabelerName": "A-S Medication Solutions LLC",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "54868-0056-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0056-3)",
      "NDC11Code": "54868-0056-03",
      "ProductNDC": "54868-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19920922",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA083177",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
      "Description": "Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate."
    },
    {
      "NDCCode": "54893-0056-6",
      "PackageDescription": "3 kg in 1 DRUM (54893-0056-6) ",
      "NDC11Code": "54893-0056-06",
      "ProductNDC": "54893-0056",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Decitabine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170131",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "MSN Laboratories Private Limited",
      "SubstanceName": "DECITABINE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-14",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "31-JAN-17"
    },
    {
      "NDCCode": "62011-0056-3",
      "PackageDescription": "1 BOTTLE in 1 BOX (62011-0056-3)  > 100 CAPSULE in 1 BOTTLE",
      "NDC11Code": "62011-0056-03",
      "ProductNDC": "62011-0056",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Multi-symptom Allergy",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120214",
      "EndMarketingDate": "20200214",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "McKesson (Health Mart)",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-02-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120214",
      "EndMarketingDatePackage": "20200214",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64025-0056-2",
      "PackageDescription": "183.3 kg in 1 SUPERSACK (64025-0056-2)",
      "NDC11Code": "64025-0056-02",
      "ProductNDC": "64025-0056",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Prasterone Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180312",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd",
      "SubstanceName": "PRASTERONE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "65085-0056-3",
      "PackageDescription": "15 kg in 1 DRUM (65085-0056-3)",
      "NDC11Code": "65085-0056-03",
      "ProductNDC": "65085-0056",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20160518",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Piramal Pharma Limited",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "kg/5kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-01-05",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "69968-0056-1",
      "PackageDescription": "1 TUBE in 1 CARTON (69968-0056-1)  / 28.3 g in 1 TUBE",
      "NDC11Code": "69968-0056-01",
      "ProductNDC": "69968-0056",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neosporin Original",
      "NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160903",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "Kenvue Brands LLC",
      "SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
      "StrengthNumber": "400; 3.5; 5000",
      "StrengthUnit": "[iU]/g; mg/g; [iU]/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-11-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160903",
      "SamplePackage": "N",
      "IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "69968-0843-9",
      "PackageDescription": "1 KIT in 1 PACKAGE (69968-0843-9)  *  1 TUBE in 1 CARTON (69968-0056-2)  / 14.2 g in 1 TUBE *  1 TUBE in 1 CARTON (69968-0056-1)  / 28.3 g in 1 TUBE",
      "NDC11Code": "69968-0843-09",
      "ProductNDC": "69968-0843",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neosporin Original",
      "NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20220601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "Kenvue Brands LLC",
      "Status": "Active",
      "LastUpdate": "2025-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220601",
      "SamplePackage": "N",
      "IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts , 2 scrapes , 3 burns."
    },
    {
      "NDCCode": "71335-0056-3",
      "PackageDescription": "10 TABLET in 1 BOTTLE (71335-0056-3) ",
      "NDC11Code": "71335-0056-03",
      "ProductNDC": "71335-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pravastatin Sodium",
      "NonProprietaryName": "Pravastatin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207068",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "PRAVASTATIN SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220502",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "85534-0056-3",
      "PackageDescription": "120 CAPSULE in 1 BOTTLE (85534-0056-3) ",
      "NDC11Code": "85534-0056-03",
      "ProductNDC": "85534-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090858",
      "LabelerName": "HAWAII REPACK, INC.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260625",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin is indicated for:  Management of postherpetic neuralgia in adults.  Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
      "Description": "The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide."
    },
    {
      "NDCCode": "49288-0242-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0242-3)",
      "NDC11Code": "49288-0242-03",
      "ProductNDC": "49288-0242",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mixture Of Standardized And Non-standardized Coastal Grasses",
      "NonProprietaryName": "Mixture Of Standardized And Non-standardized Coastal Grasses",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19970613",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103421",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN",
      "StrengthNumber": "11111; 11111; 11111; 11111; 11111; 11111; .0056; .0056; .0056",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.",
      "Description": "DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection."
    },
    {
      "NDCCode": "49288-0588-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0588-3)",
      "NDC11Code": "49288-0588-03",
      "ProductNDC": "49288-0588",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "NonProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; JUGLANS NIGRA POLLEN; PINUS CONTORTA POLLEN; JUGLANS REGIA POLLEN; QUERCUS GARRYANA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],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": "49288-0589-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0589-3)",
      "NDC11Code": "49288-0589-03",
      "ProductNDC": "49288-0589",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Inland Tree Mixture",
      "NonProprietaryName": "Washington/oregon Inland Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS TREMULOIDES POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; ACER NEGUNDO POLLEN; PINUS CONTORTA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; PINUS PONDEROSA POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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": "49288-0242-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0242-4)",
      "NDC11Code": "49288-0242-04",
      "ProductNDC": "49288-0242",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mixture Of Standardized And Non-standardized Coastal Grasses",
      "NonProprietaryName": "Mixture Of Standardized And Non-standardized Coastal Grasses",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19970613",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103421",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN",
      "StrengthNumber": "11111; 11111; 11111; 11111; 11111; 11111; .0056; .0056; .0056",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.",
      "Description": "DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection."
    },
    {
      "NDCCode": "49288-0242-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0242-5)",
      "NDC11Code": "49288-0242-05",
      "ProductNDC": "49288-0242",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mixture Of Standardized And Non-standardized Coastal Grasses",
      "NonProprietaryName": "Mixture Of Standardized And Non-standardized Coastal Grasses",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19970613",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103421",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN",
      "StrengthNumber": "11111; 11111; 11111; 11111; 11111; 11111; .0056; .0056; .0056",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.",
      "Description": "DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection."
    },
    {
      "NDCCode": "49288-0588-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0588-1)",
      "NDC11Code": "49288-0588-01",
      "ProductNDC": "49288-0588",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "NonProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; JUGLANS NIGRA POLLEN; PINUS CONTORTA POLLEN; JUGLANS REGIA POLLEN; QUERCUS GARRYANA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],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": "49288-0588-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0588-2)",
      "NDC11Code": "49288-0588-02",
      "ProductNDC": "49288-0588",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "NonProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; JUGLANS NIGRA POLLEN; PINUS CONTORTA POLLEN; JUGLANS REGIA POLLEN; QUERCUS GARRYANA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],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": "49288-0588-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0588-4)",
      "NDC11Code": "49288-0588-04",
      "ProductNDC": "49288-0588",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "NonProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; JUGLANS NIGRA POLLEN; PINUS CONTORTA POLLEN; JUGLANS REGIA POLLEN; QUERCUS GARRYANA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],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": "49288-0588-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0588-5)",
      "NDC11Code": "49288-0588-05",
      "ProductNDC": "49288-0588",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "NonProprietaryName": "Washington/oregon Coastal Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; JUGLANS NIGRA POLLEN; PINUS CONTORTA POLLEN; JUGLANS REGIA POLLEN; QUERCUS GARRYANA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],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": "49288-0589-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0589-1)",
      "NDC11Code": "49288-0589-01",
      "ProductNDC": "49288-0589",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Inland Tree Mixture",
      "NonProprietaryName": "Washington/oregon Inland Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS TREMULOIDES POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; ACER NEGUNDO POLLEN; PINUS CONTORTA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; PINUS PONDEROSA POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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": "49288-0589-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0589-2)",
      "NDC11Code": "49288-0589-02",
      "ProductNDC": "49288-0589",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Inland Tree Mixture",
      "NonProprietaryName": "Washington/oregon Inland Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS TREMULOIDES POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; ACER NEGUNDO POLLEN; PINUS CONTORTA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; PINUS PONDEROSA POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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": "49288-0589-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0589-4)",
      "NDC11Code": "49288-0589-04",
      "ProductNDC": "49288-0589",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Washington/oregon Inland Tree Mixture",
      "NonProprietaryName": "Washington/oregon Inland Tree Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19960712",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS TREMULOIDES POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; ACER NEGUNDO POLLEN; PINUS CONTORTA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; PINUS PONDEROSA POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN",
      "StrengthNumber": ".0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056",
      "StrengthUnit": "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],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],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [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],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."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"49288-0056-3","ProprietaryName":"Birch Mixture","NonProprietaryName":"Birch Mixture"},{"NDCCode":"49288-0056-1","ProprietaryName":"Birch Mixture","NonProprietaryName":"Birch Mixture"},{"NDCCode":"49288-0056-2","ProprietaryName":"Birch Mixture","NonProprietaryName":"Birch Mixture"},{"NDCCode":"49288-0056-4","ProprietaryName":"Birch Mixture","NonProprietaryName":"Birch Mixture"},{"NDCCode":"49288-0056-5","ProprietaryName":"Birch Mixture","NonProprietaryName":"Birch Mixture"},{"NDCCode":"15631-0056-3","ProprietaryName":"Artemisia Vulgaris","NonProprietaryName":"Artemisia Vulgaris"},{"NDCCode":"17337-0056-1","NonProprietaryName":"Abiraterone Acetate"},{"NDCCode":"49817-0056-3","ProprietaryName":"Lingerie De Peau Invisible Skin-fusion Foundation With Sunscreen Broad Spectrum Spf 20 02 Beige Clair","NonProprietaryName":"Octinoxate, Titanium Dioxide"},{"NDCCode":"50090-0056-3","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"54868-0056-3","ProprietaryName":"Hydrochlorothiazide","NonProprietaryName":"Hydrochlorothiazide"},{"NDCCode":"54893-0056-6","NonProprietaryName":"Decitabine"},{"NDCCode":"62011-0056-3","ProprietaryName":"Multi-symptom Allergy","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"64025-0056-2","NonProprietaryName":"Prasterone Acetate"},{"NDCCode":"65085-0056-3","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"69968-0056-1","ProprietaryName":"Neosporin Original","NonProprietaryName":"Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate"},{"NDCCode":"69968-0843-9","ProprietaryName":"Neosporin Original","NonProprietaryName":"Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate"},{"NDCCode":"71335-0056-3","ProprietaryName":"Pravastatin Sodium","NonProprietaryName":"Pravastatin Sodium"},{"NDCCode":"85534-0056-3","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"49288-0242-3","ProprietaryName":"Mixture Of Standardized And Non-standardized Coastal Grasses","NonProprietaryName":"Mixture Of Standardized And Non-standardized Coastal Grasses"},{"NDCCode":"49288-0588-3","ProprietaryName":"Washington/oregon Coastal Tree Mixture","NonProprietaryName":"Washington/oregon Coastal Tree Mixture"},{"NDCCode":"49288-0589-3","ProprietaryName":"Washington/oregon Inland Tree Mixture","NonProprietaryName":"Washington/oregon Inland Tree Mixture"},{"NDCCode":"49288-0242-4","ProprietaryName":"Mixture Of Standardized And Non-standardized Coastal Grasses","NonProprietaryName":"Mixture Of Standardized And Non-standardized Coastal Grasses"},{"NDCCode":"49288-0242-5","ProprietaryName":"Mixture Of Standardized And Non-standardized Coastal Grasses","NonProprietaryName":"Mixture Of Standardized And Non-standardized Coastal Grasses"},{"NDCCode":"49288-0588-1","ProprietaryName":"Washington/oregon Coastal Tree Mixture","NonProprietaryName":"Washington/oregon Coastal Tree Mixture"},{"NDCCode":"49288-0588-2","ProprietaryName":"Washington/oregon Coastal Tree Mixture","NonProprietaryName":"Washington/oregon Coastal Tree Mixture"},{"NDCCode":"49288-0588-4","ProprietaryName":"Washington/oregon Coastal Tree Mixture","NonProprietaryName":"Washington/oregon Coastal Tree Mixture"},{"NDCCode":"49288-0588-5","ProprietaryName":"Washington/oregon Coastal Tree Mixture","NonProprietaryName":"Washington/oregon Coastal Tree Mixture"},{"NDCCode":"49288-0589-1","ProprietaryName":"Washington/oregon Inland Tree Mixture","NonProprietaryName":"Washington/oregon Inland Tree Mixture"},{"NDCCode":"49288-0589-2","ProprietaryName":"Washington/oregon Inland Tree Mixture","NonProprietaryName":"Washington/oregon Inland Tree Mixture"},{"NDCCode":"49288-0589-4","ProprietaryName":"Washington/oregon Inland Tree Mixture","NonProprietaryName":"Washington/oregon Inland Tree Mixture"}]}
                    

<NDCList><NDC><NDCCode>49288-0056-3</NDCCode><ProprietaryName>Birch Mixture</ProprietaryName><NonProprietaryName>Birch Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0056-1</NDCCode><ProprietaryName>Birch Mixture</ProprietaryName><NonProprietaryName>Birch Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0056-2</NDCCode><ProprietaryName>Birch Mixture</ProprietaryName><NonProprietaryName>Birch Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0056-4</NDCCode><ProprietaryName>Birch Mixture</ProprietaryName><NonProprietaryName>Birch Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0056-5</NDCCode><ProprietaryName>Birch Mixture</ProprietaryName><NonProprietaryName>Birch Mixture</NonProprietaryName></NDC><NDC><NDCCode>15631-0056-3</NDCCode><ProprietaryName>Artemisia Vulgaris</ProprietaryName><NonProprietaryName>Artemisia Vulgaris</NonProprietaryName></NDC><NDC><NDCCode>17337-0056-1</NDCCode><NonProprietaryName>Abiraterone Acetate</NonProprietaryName></NDC><NDC><NDCCode>49817-0056-3</NDCCode><ProprietaryName>Lingerie De Peau Invisible Skin-fusion Foundation With Sunscreen Broad Spectrum Spf 20 02 Beige Clair</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>50090-0056-3</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>54868-0056-3</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>54893-0056-6</NDCCode><NonProprietaryName>Decitabine</NonProprietaryName></NDC><NDC><NDCCode>62011-0056-3</NDCCode><ProprietaryName>Multi-symptom Allergy</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>64025-0056-2</NDCCode><NonProprietaryName>Prasterone Acetate</NonProprietaryName></NDC><NDC><NDCCode>65085-0056-3</NDCCode><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69968-0056-1</NDCCode><ProprietaryName>Neosporin Original</ProprietaryName><NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName></NDC><NDC><NDCCode>69968-0843-9</NDCCode><ProprietaryName>Neosporin Original</ProprietaryName><NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName></NDC><NDC><NDCCode>71335-0056-3</NDCCode><ProprietaryName>Pravastatin Sodium</ProprietaryName><NonProprietaryName>Pravastatin Sodium</NonProprietaryName></NDC><NDC><NDCCode>85534-0056-3</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>49288-0242-3</NDCCode><ProprietaryName>Mixture Of Standardized And Non-standardized Coastal Grasses</ProprietaryName><NonProprietaryName>Mixture Of Standardized And Non-standardized Coastal Grasses</NonProprietaryName></NDC><NDC><NDCCode>49288-0588-3</NDCCode><ProprietaryName>Washington/oregon Coastal Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Coastal Tree Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0589-3</NDCCode><ProprietaryName>Washington/oregon Inland Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Inland Tree Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0242-4</NDCCode><ProprietaryName>Mixture Of Standardized And Non-standardized Coastal Grasses</ProprietaryName><NonProprietaryName>Mixture Of Standardized And Non-standardized Coastal Grasses</NonProprietaryName></NDC><NDC><NDCCode>49288-0242-5</NDCCode><ProprietaryName>Mixture Of Standardized And Non-standardized Coastal Grasses</ProprietaryName><NonProprietaryName>Mixture Of Standardized And Non-standardized Coastal Grasses</NonProprietaryName></NDC><NDC><NDCCode>49288-0588-1</NDCCode><ProprietaryName>Washington/oregon Coastal Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Coastal Tree Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0588-2</NDCCode><ProprietaryName>Washington/oregon Coastal Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Coastal Tree Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0588-4</NDCCode><ProprietaryName>Washington/oregon Coastal Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Coastal Tree Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0588-5</NDCCode><ProprietaryName>Washington/oregon Coastal Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Coastal Tree Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0589-1</NDCCode><ProprietaryName>Washington/oregon Inland Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Inland Tree Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0589-2</NDCCode><ProprietaryName>Washington/oregon Inland Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Inland Tree Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0589-4</NDCCode><ProprietaryName>Washington/oregon Inland Tree Mixture</ProprietaryName><NonProprietaryName>Washington/oregon Inland Tree Mixture</NonProprietaryName></NDC></NDCList>