RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "49288-0082-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0082-4)",
      "NDC11Code": "49288-0082-04",
      "ProductNDC": "49288-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eastern Cottonwood",
      "NonProprietaryName": "Eastern Cottonwood",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS DELTOIDES POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "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]",
      "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": "49288-0082-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0082-1)",
      "NDC11Code": "49288-0082-01",
      "ProductNDC": "49288-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eastern Cottonwood",
      "NonProprietaryName": "Eastern Cottonwood",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS DELTOIDES POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "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]",
      "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": "49288-0082-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0082-2)",
      "NDC11Code": "49288-0082-02",
      "ProductNDC": "49288-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eastern Cottonwood",
      "NonProprietaryName": "Eastern Cottonwood",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS DELTOIDES POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "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]",
      "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": "49288-0082-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0082-3)",
      "NDC11Code": "49288-0082-03",
      "ProductNDC": "49288-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eastern Cottonwood",
      "NonProprietaryName": "Eastern Cottonwood",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS DELTOIDES POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "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]",
      "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": "49288-0082-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0082-5)",
      "NDC11Code": "49288-0082-05",
      "ProductNDC": "49288-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eastern Cottonwood",
      "NonProprietaryName": "Eastern Cottonwood",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "POPULUS DELTOIDES POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "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]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "13630-0082-4",
      "PackageDescription": "177 mL in 1 CAN (13630-0082-4) ",
      "NDC11Code": "13630-0082-04",
      "ProductNDC": "13630-0082",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fair And Square",
      "ProprietaryNameSuffix": "Kids Broad Spectrum Spf 50",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Oxybenzone",
      "DosageFormName": "AEROSOL, SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140228",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Prime Packaging, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": "24.7; 123.6; 41.2; 49.4",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20140228",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "15631-0082-4",
      "PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0082-4) ",
      "NDC11Code": "15631-0082-04",
      "ProductNDC": "15631-0082",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blatta Americana",
      "NonProprietaryName": "Blatta Americana",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150912",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "PERIPLANETA AMERICANA",
      "StrengthNumber": "2",
      "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": "37662-0082-4",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0082-4) ",
      "NDC11Code": "37662-0082-04",
      "ProductNDC": "37662-0082",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Calcarea Fluorica",
      "NonProprietaryName": "Calcarea Fluorica",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220518",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CALCIUM FLUORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2022-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220518",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "38779-0082-4",
      "PackageDescription": "25 g in 1 JAR (38779-0082-4) ",
      "NDC11Code": "38779-0082-04",
      "ProductNDC": "38779-0082",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120217",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Medisca Inc.",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-11-14",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "17-FEB-12"
    },
    {
      "NDCCode": "50090-0082-8",
      "PackageDescription": "4 CAPSULE in 1 BOTTLE (50090-0082-8)",
      "NDC11Code": "50090-0082-08",
      "ProductNDC": "50090-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120112",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062713",
      "LabelerName": "A-S Medication Solutions LLC",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-08"
    },
    {
      "NDCCode": "53002-0082-4",
      "PackageDescription": "30 TABLET in 1 BOTTLE (53002-0082-4) ",
      "NDC11Code": "53002-0082-04",
      "ProductNDC": "53002-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acyclovir",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091022",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075382",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
      "Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
    },
    {
      "NDCCode": "58597-0082-4",
      "PackageDescription": "25 g in 1 BOTTLE (58597-0082-4)",
      "NDC11Code": "58597-0082-04",
      "ProductNDC": "58597-0082",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Oxandrolone",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140416",
      "EndMarketingDate": "20180731",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AMERICAN PHARMACEUTICAL INGREDIENTS LLC",
      "SubstanceName": "OXANDROLONE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04"
    },
    {
      "NDCCode": "61941-0082-4",
      "PackageDescription": "24 LOZENGE in 1 PACKAGE (61941-0082-4)",
      "NDC11Code": "61941-0082-04",
      "ProductNDC": "61941-0082",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold-eeze",
      "NonProprietaryName": "Zinc Gluconate",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050201",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "ProPhase Labs, Inc.",
      "SubstanceName": "ZINC GLUCONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "to reduce the duration of the common cold. reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness."
    },
    {
      "NDCCode": "70518-0082-4",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0082-4) ",
      "NDC11Code": "70518-0082-04",
      "ProductNDC": "70518-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161223",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090478",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170505",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pK a of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-( 5H –dibenzo[ a, d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
    },
    {
      "NDCCode": "71335-0082-4",
      "PackageDescription": "60 TABLET in 1 BOTTLE (71335-0082-4) ",
      "NDC11Code": "71335-0082-04",
      "ProductNDC": "71335-0082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070221",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130118",
      "SamplePackage": "N",
      "Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are:. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration."
    },
    {
      "NDCCode": "83059-0082-4",
      "PackageDescription": "1 BOTTLE in 1 CARTON (83059-0082-4)  / 40 TABLET, COATED in 1 BOTTLE",
      "NDC11Code": "83059-0082-04",
      "ProductNDC": "83059-0082",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202312",
      "LabelerName": "Shield Pharmaceuticals Corp",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250316",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache. toothache. backache. menstrual cramps. the common cold. muscular aches. minor pain of arthritis. temporarily reduces fever."
    },
    {
      "NDCCode": "49288-0001-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0001-4)",
      "NDC11Code": "49288-0001-04",
      "ProductNDC": "49288-0001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0002-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0002-4)",
      "NDC11Code": "49288-0002-04",
      "ProductNDC": "49288-0002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0003-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0003-4)",
      "NDC11Code": "49288-0003-04",
      "ProductNDC": "49288-0003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".025",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0004-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0004-4)",
      "NDC11Code": "49288-0004-04",
      "ProductNDC": "49288-0004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0017; .0017; .0017; .0017; .0067; .0067; .0067; .0067; .0067; .0067; .0033; .0033; .0022; .0022; .0011; .0011; .0011; .0011; .0011; .0011; .0067; .0067; .0067; .0067; .0067; .0022",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0005-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0005-4)",
      "NDC11Code": "49288-0005-04",
      "ProductNDC": "49288-0005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0008; .0008; .0008; .0008; .0033; .0033; .0033; .0033; .0033; .0033; .0017; .0017; .0011; .0011; .0006; .0006; .0006; .0006; .0006; .0006; .0033; .0033; .0033; .0033; .0033; .0011",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0006-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0006-4)",
      "NDC11Code": "49288-0006-04",
      "ProductNDC": "49288-0006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0004; .0004; .0004; .0004; .0017; .0017; .0017; .0017; .0017; .0017; .0008; .0008; .0006; .0006; .0003; .0003; .0003; .0003; .0003; .0003; .0017; .0017; .0017; .0017; .0017; .0006",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0007-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0007-4)",
      "NDC11Code": "49288-0007-04",
      "ProductNDC": "49288-0007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aspergillus Mixture",
      "NonProprietaryName": "Aspergillus Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS",
      "StrengthNumber": ".0025; .0025; .0025; .0025",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0008-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0008-4)",
      "NDC11Code": "49288-0008-04",
      "ProductNDC": "49288-0008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aspergillus Mixture",
      "NonProprietaryName": "Aspergillus Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS",
      "StrengthNumber": ".0125; .0125; .0125; .0125",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0009-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0009-4)",
      "NDC11Code": "49288-0009-04",
      "ProductNDC": "49288-0009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Almond",
      "NonProprietaryName": "Almond",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALMOND",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]",
      "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": "49288-0010-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0010-4)",
      "NDC11Code": "49288-0010-04",
      "ProductNDC": "49288-0010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Apple",
      "NonProprietaryName": "Apple",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "APPLE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]",
      "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": "49288-0011-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0011-4)",
      "NDC11Code": "49288-0011-04",
      "ProductNDC": "49288-0011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Apricot",
      "NonProprietaryName": "Apricot",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "APRICOT",
      "StrengthNumber": "1",
      "StrengthUnit": "mL/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]",
      "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": "49288-0012-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0012-4)",
      "NDC11Code": "49288-0012-04",
      "ProductNDC": "49288-0012",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Asparagus",
      "NonProprietaryName": "Asparagus",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPARAGUS",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [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": "49288-0013-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0013-4)",
      "NDC11Code": "49288-0013-04",
      "ProductNDC": "49288-0013",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avocado",
      "NonProprietaryName": "Avocado",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "AVOCADO",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]",
      "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": "49288-0014-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0014-4)",
      "NDC11Code": "49288-0014-04",
      "ProductNDC": "49288-0014",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acacia Pollen",
      "NonProprietaryName": "Acacia Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740423",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ACACIA BAILEYANA POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "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]",
      "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":"49288-0082-4","ProprietaryName":"Eastern Cottonwood","NonProprietaryName":"Eastern Cottonwood"},{"NDCCode":"49288-0082-1","ProprietaryName":"Eastern Cottonwood","NonProprietaryName":"Eastern Cottonwood"},{"NDCCode":"49288-0082-2","ProprietaryName":"Eastern Cottonwood","NonProprietaryName":"Eastern Cottonwood"},{"NDCCode":"49288-0082-3","ProprietaryName":"Eastern Cottonwood","NonProprietaryName":"Eastern Cottonwood"},{"NDCCode":"49288-0082-5","ProprietaryName":"Eastern Cottonwood","NonProprietaryName":"Eastern Cottonwood"},{"NDCCode":"13630-0082-4","ProprietaryName":"Fair And Square","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, And Oxybenzone"},{"NDCCode":"15631-0082-4","ProprietaryName":"Blatta Americana","NonProprietaryName":"Blatta Americana"},{"NDCCode":"37662-0082-4","ProprietaryName":"Calcarea Fluorica","NonProprietaryName":"Calcarea Fluorica"},{"NDCCode":"38779-0082-4","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"50090-0082-8","ProprietaryName":"Cephalexin","NonProprietaryName":"Cephalexin"},{"NDCCode":"53002-0082-4","ProprietaryName":"Acyclovir","NonProprietaryName":"Acyclovir"},{"NDCCode":"58597-0082-4","NonProprietaryName":"Oxandrolone"},{"NDCCode":"61941-0082-4","ProprietaryName":"Cold-eeze","NonProprietaryName":"Zinc Gluconate"},{"NDCCode":"70518-0082-4","ProprietaryName":"Cyclobenzaprine Hydrochloride","NonProprietaryName":"Cyclobenzaprine"},{"NDCCode":"71335-0082-4","ProprietaryName":"Propranolol Hydrochloride","NonProprietaryName":"Propranolol Hydrochloride"},{"NDCCode":"83059-0082-4","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"49288-0001-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0002-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0003-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0004-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0005-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0006-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0007-4","ProprietaryName":"Aspergillus Mixture","NonProprietaryName":"Aspergillus Mixture"},{"NDCCode":"49288-0008-4","ProprietaryName":"Aspergillus Mixture","NonProprietaryName":"Aspergillus Mixture"},{"NDCCode":"49288-0009-4","ProprietaryName":"Almond","NonProprietaryName":"Almond"},{"NDCCode":"49288-0010-4","ProprietaryName":"Apple","NonProprietaryName":"Apple"},{"NDCCode":"49288-0011-4","ProprietaryName":"Apricot","NonProprietaryName":"Apricot"},{"NDCCode":"49288-0012-4","ProprietaryName":"Asparagus","NonProprietaryName":"Asparagus"},{"NDCCode":"49288-0013-4","ProprietaryName":"Avocado","NonProprietaryName":"Avocado"},{"NDCCode":"49288-0014-4","ProprietaryName":"Acacia Pollen","NonProprietaryName":"Acacia Pollen"}]}
                    

<NDCList><NDC><NDCCode>49288-0082-4</NDCCode><ProprietaryName>Eastern Cottonwood</ProprietaryName><NonProprietaryName>Eastern Cottonwood</NonProprietaryName></NDC><NDC><NDCCode>49288-0082-1</NDCCode><ProprietaryName>Eastern Cottonwood</ProprietaryName><NonProprietaryName>Eastern Cottonwood</NonProprietaryName></NDC><NDC><NDCCode>49288-0082-2</NDCCode><ProprietaryName>Eastern Cottonwood</ProprietaryName><NonProprietaryName>Eastern Cottonwood</NonProprietaryName></NDC><NDC><NDCCode>49288-0082-3</NDCCode><ProprietaryName>Eastern Cottonwood</ProprietaryName><NonProprietaryName>Eastern Cottonwood</NonProprietaryName></NDC><NDC><NDCCode>49288-0082-5</NDCCode><ProprietaryName>Eastern Cottonwood</ProprietaryName><NonProprietaryName>Eastern Cottonwood</NonProprietaryName></NDC><NDC><NDCCode>13630-0082-4</NDCCode><ProprietaryName>Fair And Square</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>15631-0082-4</NDCCode><ProprietaryName>Blatta Americana</ProprietaryName><NonProprietaryName>Blatta Americana</NonProprietaryName></NDC><NDC><NDCCode>37662-0082-4</NDCCode><ProprietaryName>Calcarea Fluorica</ProprietaryName><NonProprietaryName>Calcarea Fluorica</NonProprietaryName></NDC><NDC><NDCCode>38779-0082-4</NDCCode><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-0082-8</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC><NDC><NDCCode>53002-0082-4</NDCCode><ProprietaryName>Acyclovir</ProprietaryName><NonProprietaryName>Acyclovir</NonProprietaryName></NDC><NDC><NDCCode>58597-0082-4</NDCCode><NonProprietaryName>Oxandrolone</NonProprietaryName></NDC><NDC><NDCCode>61941-0082-4</NDCCode><ProprietaryName>Cold-eeze</ProprietaryName><NonProprietaryName>Zinc Gluconate</NonProprietaryName></NDC><NDC><NDCCode>70518-0082-4</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine</NonProprietaryName></NDC><NDC><NDCCode>71335-0082-4</NDCCode><ProprietaryName>Propranolol Hydrochloride</ProprietaryName><NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>83059-0082-4</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>49288-0001-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0002-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0003-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0004-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0005-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0006-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0007-4</NDCCode><ProprietaryName>Aspergillus Mixture</ProprietaryName><NonProprietaryName>Aspergillus Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0008-4</NDCCode><ProprietaryName>Aspergillus Mixture</ProprietaryName><NonProprietaryName>Aspergillus Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0009-4</NDCCode><ProprietaryName>Almond</ProprietaryName><NonProprietaryName>Almond</NonProprietaryName></NDC><NDC><NDCCode>49288-0010-4</NDCCode><ProprietaryName>Apple</ProprietaryName><NonProprietaryName>Apple</NonProprietaryName></NDC><NDC><NDCCode>49288-0011-4</NDCCode><ProprietaryName>Apricot</ProprietaryName><NonProprietaryName>Apricot</NonProprietaryName></NDC><NDC><NDCCode>49288-0012-4</NDCCode><ProprietaryName>Asparagus</ProprietaryName><NonProprietaryName>Asparagus</NonProprietaryName></NDC><NDC><NDCCode>49288-0013-4</NDCCode><ProprietaryName>Avocado</ProprietaryName><NonProprietaryName>Avocado</NonProprietaryName></NDC><NDC><NDCCode>49288-0014-4</NDCCode><ProprietaryName>Acacia Pollen</ProprietaryName><NonProprietaryName>Acacia Pollen</NonProprietaryName></NDC></NDCList>