{
"NDC": [
{
"NDCCode": "49288-0574-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0574-4)",
"NDC11Code": "49288-0574-04",
"ProductNDC": "49288-0574",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tree Of Heaven",
"NonProprietaryName": "Tree Of Heaven",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "AILANTHUS ALTISSIMA 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."
},
{
"NDCCode": "49288-0574-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0574-1)",
"NDC11Code": "49288-0574-01",
"ProductNDC": "49288-0574",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tree Of Heaven",
"NonProprietaryName": "Tree Of Heaven",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "AILANTHUS ALTISSIMA 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."
},
{
"NDCCode": "49288-0574-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0574-2)",
"NDC11Code": "49288-0574-02",
"ProductNDC": "49288-0574",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tree Of Heaven",
"NonProprietaryName": "Tree Of Heaven",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "AILANTHUS ALTISSIMA 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."
},
{
"NDCCode": "49288-0574-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0574-3)",
"NDC11Code": "49288-0574-03",
"ProductNDC": "49288-0574",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tree Of Heaven",
"NonProprietaryName": "Tree Of Heaven",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "AILANTHUS ALTISSIMA 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."
},
{
"NDCCode": "49288-0574-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0574-5)",
"NDC11Code": "49288-0574-05",
"ProductNDC": "49288-0574",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tree Of Heaven",
"NonProprietaryName": "Tree Of Heaven",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "AILANTHUS ALTISSIMA 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."
},
{
"NDCCode": "0574-0425-04",
"PackageDescription": "4 L in 1 JUG (0574-0425-04)",
"NDC11Code": "00574-0425-04",
"ProductNDC": "0574-0425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079232",
"LabelerName": "Paddock Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "420",
"StrengthUnit": "g/4L",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2015-01-30"
},
{
"NDCCode": "0574-0426-04",
"PackageDescription": "4 L in 1 JUG (0574-0426-04)",
"NDC11Code": "00574-0426-04",
"ProductNDC": "0574-0426",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350 And Electrolytes",
"ProprietaryNameSuffix": "With Flavor Packs",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090712",
"LabelerName": "Paddock Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "60",
"StrengthUnit": "g/L",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2015-04-17"
},
{
"NDCCode": "0574-0427-04",
"PackageDescription": "4 L in 1 JUG (0574-0427-04)",
"NDC11Code": "00574-0427-04",
"ProductNDC": "0574-0427",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clenz-lyte",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "NASOGASTRIC; ORAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090769",
"LabelerName": "Paddock Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "236; 2.97; 6.74; 5.86; 22.74",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-05-22"
},
{
"NDCCode": "0574-0428-04",
"PackageDescription": "4 L in 1 JUG (0574-0428-04)",
"NDC11Code": "00574-0428-04",
"ProductNDC": "0574-0428",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350 And Electrolytes",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090712",
"LabelerName": "Paddock Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "60",
"StrengthUnit": "g/L",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2015-04-17"
},
{
"NDCCode": "0574-0805-30",
"PackageDescription": "4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIAL",
"NDC11Code": "00574-0805-30",
"ProductNDC": "0574-0805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20121220",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021539",
"LabelerName": "Padagis US LLC",
"SubstanceName": "ACETYLCYSTEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121220",
"SamplePackage": "N",
"IndicationAndUsage": "Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI).",
"Description": "Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula. Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine Injection contains the following inactive ingredients: sodium hydroxide (used for pH adjustment), and Water for Injection, USP. The amount of sodium in Acetylcysteine Injection is approximately 30 mg/mL. Because Acetylcysteine Injection is administered based on a patient’s weight, the amount of sodium administered in a course of treatment will vary from approximately 225 mg to 4500 mg. The use of ½ normal saline will contribute approximately an additional 1770 mg of sodium per liter of diluent."
},
{
"NDCCode": "0574-0815-30",
"PackageDescription": "4 VIAL in 1 CARTON (0574-0815-30) > 30 mL in 1 VIAL",
"NDC11Code": "00574-0815-30",
"ProductNDC": "0574-0815",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20131015",
"EndMarketingDate": "20210201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021539",
"LabelerName": "Paddock Laboratories, LLC",
"SubstanceName": "ACETYLCYSTEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131015",
"EndMarketingDatePackage": "20210201",
"SamplePackage": "N"
},
{
"NDCCode": "0574-7040-04",
"PackageDescription": "4 PACKET in 1 BOX (0574-7040-04) / 1 SUPPOSITORY in 1 PACKET",
"NDC11Code": "00574-7040-04",
"ProductNDC": "0574-7040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belladonna And Opium",
"NonProprietaryName": "Atropa Belladonna And Opium",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "19970422",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Padagis US LLC",
"SubstanceName": "ATROPA BELLADONNA; OPIUM",
"StrengthNumber": "16.2; 60",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180822",
"SamplePackage": "N",
"IndicationAndUsage": "Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60). Belladonna (16.2 mg) and Opium (30 mg). Powdered belladonna extract 16.2 mg and powdered opium 30 mg. Belladonna (16.2 mg) and Opium (60 mg). Powdered belladonna extract 16.2 mg and powdered opium 60 mg. This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents. The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are. Established Name: Atropine. Chemical Name: dl Tropyl Tropate. Established Name: Scopolamine. Chemical Name: dl Scopolamine. Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is. Name: Morphine. Chemical Name: 7, 8-Didehydro-4, 5-epoxy-17-Methyl-morphinan-3, 6-diol."
},
{
"NDCCode": "0574-7045-04",
"PackageDescription": "4 PACKET in 1 BOX (0574-7045-04) / 1 SUPPOSITORY in 1 PACKET",
"NDC11Code": "00574-7045-04",
"ProductNDC": "0574-7045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Belladonna And Opium",
"NonProprietaryName": "Atropa Belladonna And Opium",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "19940501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Padagis US LLC",
"SubstanceName": "ATROPA BELLADONNA; OPIUM",
"StrengthNumber": "16.2; 30",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180822",
"SamplePackage": "N",
"IndicationAndUsage": "Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60). Belladonna (16.2 mg) and Opium (30 mg). Powdered belladonna extract 16.2 mg and powdered opium 30 mg. Belladonna (16.2 mg) and Opium (60 mg). Powdered belladonna extract 16.2 mg and powdered opium 60 mg. This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents. The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are. Established Name: Atropine. Chemical Name: dl Tropyl Tropate. Established Name: Scopolamine. Chemical Name: dl Scopolamine. Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is. Name: Morphine. Chemical Name: 7, 8-Didehydro-4, 5-epoxy-17-Methyl-morphinan-3, 6-diol."
},
{
"NDCCode": "12658-0574-1",
"PackageDescription": "4 kg in 1 DRUM (12658-0574-1)",
"NDC11Code": "12658-0574-01",
"ProductNDC": "12658-0574",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140108",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pharmaceutical Works POLPHARMA",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "4",
"StrengthUnit": "kg/4kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "15631-0574-1",
"PackageDescription": "4 TABLET in 1 BLISTER PACK (15631-0574-1)",
"NDC11Code": "15631-0574-01",
"ProductNDC": "15631-0574",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dioscorea Villosa",
"NonProprietaryName": "Dioscorea Villosa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151227",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "DIOSCOREA VILLOSA TUBER",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0574-4",
"PackageDescription": "250 TABLET in 1 CONTAINER (15631-0574-4)",
"NDC11Code": "15631-0574-04",
"ProductNDC": "15631-0574",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dioscorea Villosa",
"NonProprietaryName": "Dioscorea Villosa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151227",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "DIOSCOREA VILLOSA TUBER",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0574-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0574-4) ",
"NDC11Code": "37662-0574-04",
"ProductNDC": "37662-0574",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cryptomeria Japonica",
"NonProprietaryName": "Cryptomeria Japonica",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220721",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CRYPTOMERIA JAPONICA WHOLE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-07-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220721",
"SamplePackage": "N"
},
{
"NDCCode": "38779-0574-4",
"PackageDescription": "25 g in 1 JAR (38779-0574-4) ",
"NDC11Code": "38779-0574-04",
"ProductNDC": "38779-0574",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "POWDER",
"StartMarketingDate": "20081204",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-09-05",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "04-DEC-08"
},
{
"NDCCode": "65692-0574-1",
"PackageDescription": "4.25 g in 1 TUBE (65692-0574-1) ",
"NDC11Code": "65692-0574-01",
"ProductNDC": "65692-0574",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Broad Spectrum Spf 15 Sunscreen Vanilla Mint Lip Balm",
"NonProprietaryName": "Broad Spectrum Spf 15 Sunscreen Vanilla Mint Lip Balm",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Raining Rose",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": ".13; .28; .06; .21",
"StrengthUnit": "g/4.25g; g/4.25g; g/4.25g; g/4.25g",
"Status": "Active",
"LastUpdate": "2023-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221213",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "71335-0574-4",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (71335-0574-4) ",
"NDC11Code": "71335-0574-04",
"ProductNDC": "71335-0574",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091166",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150717",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methylpiperazine-1-carboxylic acid 6-(5-chloro-2-pyridyl)-7-oxo-6, 7-dihydro-5 H-pyrrolo [3,4-b]pyrazin-5(S)-yl ester. Its molecular weight is 388.81 g/mol, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light yellow powder. Eszopiclone is slightly soluble in acetone, methanol and alcohol; practically insoluble in water. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone Tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2."
},
{
"NDCCode": "76420-650-01",
"PackageDescription": "1 KIT in 1 CARTON (76420-650-01) * 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS * 1.4 mL in 1 POUCH",
"NDC11Code": "76420-0650-01",
"ProductNDC": "76420-650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testone Cik",
"NonProprietaryName": "Testosterone Cypionate, Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20071221",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Asclemed USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160523",
"SamplePackage": "N"
},
{
"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."
}
]
}
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<NDCList>
<NDC>
<NDCCode>49288-0574-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0574-4)</PackageDescription>
<NDC11Code>49288-0574-04</NDC11Code>
<ProductNDC>49288-0574</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tree Of Heaven</ProprietaryName>
<NonProprietaryName>Tree Of Heaven</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>AILANTHUS ALTISSIMA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0574-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0574-1)</PackageDescription>
<NDC11Code>49288-0574-01</NDC11Code>
<ProductNDC>49288-0574</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tree Of Heaven</ProprietaryName>
<NonProprietaryName>Tree Of Heaven</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>AILANTHUS ALTISSIMA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0574-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0574-2)</PackageDescription>
<NDC11Code>49288-0574-02</NDC11Code>
<ProductNDC>49288-0574</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tree Of Heaven</ProprietaryName>
<NonProprietaryName>Tree Of Heaven</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>AILANTHUS ALTISSIMA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0574-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0574-3)</PackageDescription>
<NDC11Code>49288-0574-03</NDC11Code>
<ProductNDC>49288-0574</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tree Of Heaven</ProprietaryName>
<NonProprietaryName>Tree Of Heaven</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>AILANTHUS ALTISSIMA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0574-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0574-5)</PackageDescription>
<NDC11Code>49288-0574-05</NDC11Code>
<ProductNDC>49288-0574</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tree Of Heaven</ProprietaryName>
<NonProprietaryName>Tree Of Heaven</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>AILANTHUS ALTISSIMA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>0574-0425-04</NDCCode>
<PackageDescription>4 L in 1 JUG (0574-0425-04)</PackageDescription>
<NDC11Code>00574-0425-04</NDC11Code>
<ProductNDC>0574-0425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079232</ApplicationNumber>
<LabelerName>Paddock Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>g/4L</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>0574-0426-04</NDCCode>
<PackageDescription>4 L in 1 JUG (0574-0426-04)</PackageDescription>
<NDC11Code>00574-0426-04</NDC11Code>
<ProductNDC>0574-0426</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350 And Electrolytes</ProprietaryName>
<ProprietaryNameSuffix>With Flavor Packs</ProprietaryNameSuffix>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090712</ApplicationNumber>
<LabelerName>Paddock Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>g/L</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>0574-0427-04</NDCCode>
<PackageDescription>4 L in 1 JUG (0574-0427-04)</PackageDescription>
<NDC11Code>00574-0427-04</NDC11Code>
<ProductNDC>0574-0427</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clenz-lyte</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>NASOGASTRIC; ORAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090769</ApplicationNumber>
<LabelerName>Paddock Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS</SubstanceName>
<StrengthNumber>236; 2.97; 6.74; 5.86; 22.74</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0574-0428-04</NDCCode>
<PackageDescription>4 L in 1 JUG (0574-0428-04)</PackageDescription>
<NDC11Code>00574-0428-04</NDC11Code>
<ProductNDC>0574-0428</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350 And Electrolytes</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090712</ApplicationNumber>
<LabelerName>Paddock Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>g/L</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>0574-0805-30</NDCCode>
<PackageDescription>4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>00574-0805-30</NDC11Code>
<ProductNDC>0574-0805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetylcysteine</ProprietaryName>
<NonProprietaryName>Acetylcysteine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20121220</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021539</ApplicationNumber>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>ACETYLCYSTEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI).</IndicationAndUsage>
<Description>Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula. Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine Injection contains the following inactive ingredients: sodium hydroxide (used for pH adjustment), and Water for Injection, USP. The amount of sodium in Acetylcysteine Injection is approximately 30 mg/mL. Because Acetylcysteine Injection is administered based on a patient’s weight, the amount of sodium administered in a course of treatment will vary from approximately 225 mg to 4500 mg. The use of ½ normal saline will contribute approximately an additional 1770 mg of sodium per liter of diluent.</Description>
</NDC>
<NDC>
<NDCCode>0574-0815-30</NDCCode>
<PackageDescription>4 VIAL in 1 CARTON (0574-0815-30) > 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>00574-0815-30</NDC11Code>
<ProductNDC>0574-0815</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetylcysteine</ProprietaryName>
<NonProprietaryName>Acetylcysteine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20131015</StartMarketingDate>
<EndMarketingDate>20210201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021539</ApplicationNumber>
<LabelerName>Paddock Laboratories, LLC</LabelerName>
<SubstanceName>ACETYLCYSTEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131015</StartMarketingDatePackage>
<EndMarketingDatePackage>20210201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0574-7040-04</NDCCode>
<PackageDescription>4 PACKET in 1 BOX (0574-7040-04) / 1 SUPPOSITORY in 1 PACKET</PackageDescription>
<NDC11Code>00574-7040-04</NDC11Code>
<ProductNDC>0574-7040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belladonna And Opium</ProprietaryName>
<NonProprietaryName>Atropa Belladonna And Opium</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19970422</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>ATROPA BELLADONNA; OPIUM</SubstanceName>
<StrengthNumber>16.2; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60). Belladonna (16.2 mg) and Opium (30 mg). Powdered belladonna extract 16.2 mg and powdered opium 30 mg. Belladonna (16.2 mg) and Opium (60 mg). Powdered belladonna extract 16.2 mg and powdered opium 60 mg. This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents. The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are. Established Name: Atropine. Chemical Name: dl Tropyl Tropate. Established Name: Scopolamine. Chemical Name: dl Scopolamine. Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is. Name: Morphine. Chemical Name: 7, 8-Didehydro-4, 5-epoxy-17-Methyl-morphinan-3, 6-diol.</Description>
</NDC>
<NDC>
<NDCCode>0574-7045-04</NDCCode>
<PackageDescription>4 PACKET in 1 BOX (0574-7045-04) / 1 SUPPOSITORY in 1 PACKET</PackageDescription>
<NDC11Code>00574-7045-04</NDC11Code>
<ProductNDC>0574-7045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Belladonna And Opium</ProprietaryName>
<NonProprietaryName>Atropa Belladonna And Opium</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19940501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>ATROPA BELLADONNA; OPIUM</SubstanceName>
<StrengthNumber>16.2; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60). Belladonna (16.2 mg) and Opium (30 mg). Powdered belladonna extract 16.2 mg and powdered opium 30 mg. Belladonna (16.2 mg) and Opium (60 mg). Powdered belladonna extract 16.2 mg and powdered opium 60 mg. This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents. The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are. Established Name: Atropine. Chemical Name: dl Tropyl Tropate. Established Name: Scopolamine. Chemical Name: dl Scopolamine. Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is. Name: Morphine. Chemical Name: 7, 8-Didehydro-4, 5-epoxy-17-Methyl-morphinan-3, 6-diol.</Description>
</NDC>
<NDC>
<NDCCode>12658-0574-1</NDCCode>
<PackageDescription>4 kg in 1 DRUM (12658-0574-1)</PackageDescription>
<NDC11Code>12658-0574-01</NDC11Code>
<ProductNDC>12658-0574</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pharmaceutical Works POLPHARMA</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>kg/4kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15631-0574-1</NDCCode>
<PackageDescription>4 TABLET in 1 BLISTER PACK (15631-0574-1)</PackageDescription>
<NDC11Code>15631-0574-01</NDC11Code>
<ProductNDC>15631-0574</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dioscorea Villosa</ProprietaryName>
<NonProprietaryName>Dioscorea Villosa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>DIOSCOREA VILLOSA TUBER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0574-4</NDCCode>
<PackageDescription>250 TABLET in 1 CONTAINER (15631-0574-4)</PackageDescription>
<NDC11Code>15631-0574-04</NDC11Code>
<ProductNDC>15631-0574</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dioscorea Villosa</ProprietaryName>
<NonProprietaryName>Dioscorea Villosa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>DIOSCOREA VILLOSA TUBER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0574-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-0574-4) </PackageDescription>
<NDC11Code>37662-0574-04</NDC11Code>
<ProductNDC>37662-0574</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cryptomeria Japonica</ProprietaryName>
<NonProprietaryName>Cryptomeria Japonica</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220721</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CRYPTOMERIA JAPONICA WHOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>38779-0574-4</NDCCode>
<PackageDescription>25 g in 1 JAR (38779-0574-4) </PackageDescription>
<NDC11Code>38779-0574-04</NDC11Code>
<ProductNDC>38779-0574</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20081204</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-05</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-DEC-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65692-0574-1</NDCCode>
<PackageDescription>4.25 g in 1 TUBE (65692-0574-1) </PackageDescription>
<NDC11Code>65692-0574-01</NDC11Code>
<ProductNDC>65692-0574</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Broad Spectrum Spf 15 Sunscreen Vanilla Mint Lip Balm</ProprietaryName>
<NonProprietaryName>Broad Spectrum Spf 15 Sunscreen Vanilla Mint Lip Balm</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Raining Rose</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>.13; .28; .06; .21</StrengthNumber>
<StrengthUnit>g/4.25g; g/4.25g; g/4.25g; g/4.25g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-0574-4</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (71335-0574-4) </PackageDescription>
<NDC11Code>71335-0574-04</NDC11Code>
<ProductNDC>71335-0574</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091166</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methylpiperazine-1-carboxylic acid 6-(5-chloro-2-pyridyl)-7-oxo-6, 7-dihydro-5 H-pyrrolo [3,4-b]pyrazin-5(S)-yl ester. Its molecular weight is 388.81 g/mol, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light yellow powder. Eszopiclone is slightly soluble in acetone, methanol and alcohol; practically insoluble in water. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone Tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>76420-650-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-650-01) * 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS * 1.4 mL in 1 POUCH</PackageDescription>
<NDC11Code>76420-0650-01</NDC11Code>
<ProductNDC>76420-650</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testone Cik</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate, Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20071221</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0001-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0001-4)</PackageDescription>
<NDC11Code>49288-0001-04</NDC11Code>
<ProductNDC>49288-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alternaria Alternata</ProprietaryName>
<NonProprietaryName>Alternaria Alternata</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920413</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0002-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0002-4)</PackageDescription>
<NDC11Code>49288-0002-04</NDC11Code>
<ProductNDC>49288-0002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alternaria Alternata</ProprietaryName>
<NonProprietaryName>Alternaria Alternata</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0003-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0003-4)</PackageDescription>
<NDC11Code>49288-0003-04</NDC11Code>
<ProductNDC>49288-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alternaria Alternata</ProprietaryName>
<NonProprietaryName>Alternaria Alternata</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0004-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0004-4)</PackageDescription>
<NDC11Code>49288-0004-04</NDC11Code>
<ProductNDC>49288-0004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>A Mold Mixture</ProprietaryName>
<NonProprietaryName>A Mold Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920413</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<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</SubstanceName>
<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</StrengthNumber>
<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</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0005-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0005-4)</PackageDescription>
<NDC11Code>49288-0005-04</NDC11Code>
<ProductNDC>49288-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>A Mold Mixture</ProprietaryName>
<NonProprietaryName>A Mold Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>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</SubstanceName>
<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</StrengthNumber>
<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</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0006-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0006-4)</PackageDescription>
<NDC11Code>49288-0006-04</NDC11Code>
<ProductNDC>49288-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>A Mold Mixture</ProprietaryName>
<NonProprietaryName>A Mold Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>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</SubstanceName>
<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</StrengthNumber>
<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</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0007-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0007-4)</PackageDescription>
<NDC11Code>49288-0007-04</NDC11Code>
<ProductNDC>49288-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspergillus Mixture</ProprietaryName>
<NonProprietaryName>Aspergillus Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS</SubstanceName>
<StrengthNumber>.0025; .0025; .0025; .0025</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0008-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0008-4)</PackageDescription>
<NDC11Code>49288-0008-04</NDC11Code>
<ProductNDC>49288-0008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspergillus Mixture</ProprietaryName>
<NonProprietaryName>Aspergillus Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS</SubstanceName>
<StrengthNumber>.0125; .0125; .0125; .0125</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0009-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0009-4)</PackageDescription>
<NDC11Code>49288-0009-04</NDC11Code>
<ProductNDC>49288-0009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Almond</ProprietaryName>
<NonProprietaryName>Almond</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ALMOND</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
</NDCList>