RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "49288-0173-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0173-4)",
      "NDC11Code": "49288-0173-04",
      "ProductNDC": "49288-0173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite, Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Standardized Mite, Dermatophagoides Pteronyssinus",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920206",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102225",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "3000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated 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. An orderly approach to the 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.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).",
      "Description": "DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period."
    },
    {
      "NDCCode": "49288-0173-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0173-3)",
      "NDC11Code": "49288-0173-03",
      "ProductNDC": "49288-0173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite, Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Standardized Mite, Dermatophagoides Pteronyssinus",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920206",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102225",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "3000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated 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. An orderly approach to the 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.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).",
      "Description": "DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period."
    },
    {
      "NDCCode": "49288-0173-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0173-5)",
      "NDC11Code": "49288-0173-05",
      "ProductNDC": "49288-0173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite, Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Standardized Mite, Dermatophagoides Pteronyssinus",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920206",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102225",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "3000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated 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. An orderly approach to the 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.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).",
      "Description": "DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period."
    },
    {
      "NDCCode": "0173-0681-01",
      "PackageDescription": "5 PACKAGE in 1 CARTON (0173-0681-01)  / 4 POWDER in 1 PACKAGE",
      "NDC11Code": "00173-0681-01",
      "ProductNDC": "0173-0681",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Relenza",
      "NonProprietaryName": "Zanamivir",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19990922",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021036",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "ZANAMIVIR",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19990922",
      "SamplePackage": "N",
      "IndicationAndUsage": "RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for. Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. (1.1). Prophylaxis of influenza in patients aged 5 years and older. (1.2). Important Limitations of Use. Not recommended for treatment or prophylaxis of influenza in: 1 Individuals with underlying airways disease. (5.1).",
      "Description": "The active component of RELENZA is zanamivir. The chemical name of zanamivir is 5-(acetylamino)-4-[(aminoiminomethyl)-amino]-2,6-anhydro-3,4,5-trideoxy-D-glycero-D-galacto-non-2-enonic acid. It has a molecular formula of C12H20N4O7 and a molecular weight of 332.3. It has the following structural formula. Zanamivir is a white to off-white powder for oral inhalation with a solubility of approximately 18 mg/mL in water at 20°C. RELENZA is for administration to the respiratory tract by oral inhalation only. Each RELENZA ROTADISK contains 4 regularly spaced double-foil blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose (which contains milk proteins). The contents of each blister are inhaled using a specially designed breath-activated plastic device for inhaling powder called the DISKHALER. After a RELENZA ROTADISK is loaded into the DISKHALER, a blister that contains medication is pierced and the zanamivir is dispersed into the air stream created when the patient inhales through the mouthpiece. The amount of drug delivered to the respiratory tract will depend on patient factors such as inspiratory flow. Under standardized in vitro testing, RELENZA ROTADISK delivers 4 mg of zanamivir from the DISKHALER device when tested at a pressure drop of 3 kPa (corresponding to a flow rate of about 62 to 65 L/minute) for 3 seconds."
    },
    {
      "NDCCode": "0173-0681-22",
      "PackageDescription": "5 PACKAGE in 1 CARTON (0173-0681-22)  / 4 POWDER in 1 PACKAGE",
      "NDC11Code": "00173-0681-22",
      "ProductNDC": "0173-0681",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Relenza",
      "NonProprietaryName": "Zanamivir",
      "DosageFormName": "POWDER",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19990922",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021036",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "ZANAMIVIR",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070309",
      "SamplePackage": "N",
      "IndicationAndUsage": "RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for. Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. (1.1). Prophylaxis of influenza in patients aged 5 years and older. (1.2). Important Limitations of Use. Not recommended for treatment or prophylaxis of influenza in: 1 Individuals with underlying airways disease. (5.1).",
      "Description": "The active component of RELENZA is zanamivir. The chemical name of zanamivir is 5-(acetylamino)-4-[(aminoiminomethyl)-amino]-2,6-anhydro-3,4,5-trideoxy-D-glycero-D-galacto-non-2-enonic acid. It has a molecular formula of C12H20N4O7 and a molecular weight of 332.3. It has the following structural formula. Zanamivir is a white to off-white powder for oral inhalation with a solubility of approximately 18 mg/mL in water at 20°C. RELENZA is for administration to the respiratory tract by oral inhalation only. Each RELENZA ROTADISK contains 4 regularly spaced double-foil blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose (which contains milk proteins). The contents of each blister are inhaled using a specially designed breath-activated plastic device for inhaling powder called the DISKHALER. After a RELENZA ROTADISK is loaded into the DISKHALER, a blister that contains medication is pierced and the zanamivir is dispersed into the air stream created when the patient inhales through the mouthpiece. The amount of drug delivered to the respiratory tract will depend on patient factors such as inspiratory flow. Under standardized in vitro testing, RELENZA ROTADISK delivers 4 mg of zanamivir from the DISKHALER device when tested at a pressure drop of 3 kPa (corresponding to a flow rate of about 62 to 65 L/minute) for 3 seconds."
    },
    {
      "NDCCode": "0173-0783-62",
      "PackageDescription": "4 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0783-62)",
      "NDC11Code": "00173-0783-62",
      "ProductNDC": "0173-0783",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lovaza",
      "NonProprietaryName": "Omega-3-acid Ethyl Esters",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081021",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021654",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "OMEGA-3-ACID ETHYL ESTERS",
      "StrengthNumber": "900",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "0173-0822-04",
      "PackageDescription": "1 BLISTER PACK in 1 BOX (0173-0822-04)  > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "00173-0822-04",
      "ProductNDC": "0173-0822",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Staxyn",
      "NonProprietaryName": "Vardenafil Hydrochloride",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110421",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200179",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "VARDENAFIL HYDROCHLORIDE",
      "StrengthNumber": "11.85",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-04-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20110421",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0173-0822-14",
      "PackageDescription": "10 BLISTER PACK in 1 BOX (0173-0822-14)  > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "00173-0822-14",
      "ProductNDC": "0173-0822",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Staxyn",
      "NonProprietaryName": "Vardenafil Hydrochloride",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110421",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA200179",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "VARDENAFIL HYDROCHLORIDE",
      "StrengthNumber": "11.85",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-01-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20110421",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0173-0866-35",
      "PackageDescription": "4 SYRINGE in 1 CARTON (0173-0866-35)  > .5 mL in 1 SYRINGE (0173-0866-01) ",
      "NDC11Code": "00173-0866-35",
      "ProductNDC": "0173-0866",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tanzeum",
      "NonProprietaryName": "Albiglutide",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20140415",
      "EndMarketingDate": "20200930",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125431",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "ALBIGLUTIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/.5mL",
      "Pharm_Classes": "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA],GLP-1 Receptor Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140415",
      "EndMarketingDatePackage": "20200930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0173-0867-35",
      "PackageDescription": "4 SYRINGE in 1 CARTON (0173-0867-35)  > .5 mL in 1 SYRINGE (0173-0867-01) ",
      "NDC11Code": "00173-0867-35",
      "ProductNDC": "0173-0867",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tanzeum",
      "NonProprietaryName": "Albiglutide",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20140415",
      "EndMarketingDate": "20200831",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125431",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "ALBIGLUTIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/.5mL",
      "Pharm_Classes": "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA],GLP-1 Receptor Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20140415",
      "EndMarketingDatePackage": "20200831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0173-0904-42",
      "PackageDescription": "1 SYRINGE in 1 CARTON (0173-0904-42)  / .4 mL in 1 SYRINGE",
      "NDC11Code": "00173-0904-42",
      "ProductNDC": "0173-0904",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nucala",
      "NonProprietaryName": "Mepolizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20220122",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761122",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "MEPOLIZUMAB",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/.4mL",
      "Pharm_Classes": "Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220122",
      "SamplePackage": "N",
      "IndicationAndUsage": "NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: 1 Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. (1.1), 2 Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). (1.2), 3 Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (1.3), 4 The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (1.4), 5 The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause. (1.5).",
      "Description": "Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Mepolizumab has a molecular weight of approximately 149 kDa. NUCALA for injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial for subcutaneous injection after reconstitution. Upon reconstitution with 1.2 mL of Sterile Water for Injection, USP, the resulting concentration is 100 mg/mL and delivers 1 mL [see Dosage and Administration (2.2)]. Each vial delivers 100 mg of mepolizumab, polysorbate 80 (0.67 mg), sodium phosphate dibasic heptahydrate (7.14 mg), and sucrose (160 mg), with a pH of 7.0. The vial stopper is not made with natural rubber latex. NUCALA injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brown solution for subcutaneous use. NUCALA injection is supplied in a single-dose, 1-mL, prefilled autoinjector with a fixed 29‑gauge, half-inch needle and in a single-dose, 1-mL, prefilled syringe with a fixed 29‑gauge, half-inch needle with a needle guard. Each 1 mL delivers 100 mg mepolizumab, citric acid monohydrate (0.95 mg), EDTA disodium dihydrate (0.019 mg), polysorbate 80 (0.20 mg), sodium phosphate dibasic heptahydrate (4.16 mg), and sucrose (120 mg), with a pH of 6.3. NUCALA injection is supplied in a single-dose, 0.4-mL, prefilled syringe with a fixed 29-gauge, half-inch needle with a needle guard. Each 0.4 mL delivers 40 mg mepolizumab, citric acid monohydrate (0.38 mg), EDTA disodium dihydrate (0.0074 mg), polysorbate 80 (0.08 mg), sodium phosphate dibasic heptahydrate (1.66 mg), and sucrose (48 mg), with a pH of 6.3. The prefilled autoinjector and prefilled syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "0173-0913-01",
      "PackageDescription": "1 VIAL in 1 CARTON (0173-0913-01)  / 1.4 mL in 1 VIAL",
      "NDC11Code": "00173-0913-01",
      "ProductNDC": "0173-0913",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Blenrep",
      "NonProprietaryName": "Belantamab Mafodotin",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20251023",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761440",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "BELANTAMAB MAFODOTIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251023",
      "SamplePackage": "N",
      "IndicationAndUsage": "BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.",
      "Description": "Belantamab mafodotin‑blmf is a B‑cell maturation antigen (BCMA)‑directed antibody and microtubule inhibitor conjugate. Belantamab mafodotin‑blmf is an antibody conjugate composed of 3 components: 1) afucosylated, humanized immunoglobulin G1 monoclonal antibody covalently linked to 2) the microtubule inhibitor mcMMAF via 3) a protease‑resistant maleimidocaproyl linker. The antibody is produced in a mammalian cell line (Chinese Hamster Ovary) using recombinant DNA technology and the microtubule inhibitor and linker are produced by chemical synthesis. Approximately 4 molecules of mafodotin are attached to each antibody molecule. The molecular weight of belantamab mafodotin‑blmf is approximately 152 kDa. Belantamab mafodotin‑blmf has the following structure. BLENREP (belantamab mafodotin‑blmf) for injection is a sterile, preservative‑free, white to yellow, lyophilized powder in a single‑dose vial for reconstitution and further dilution prior to intravenous use. BLENREP is supplied as 70 mg per vial and requires reconstitution with 1.4 mL of Sterile Water for Injection, USP, to obtain a concentration of 50 mg/mL. Each mL of reconstituted solution contains belantamab mafodotin‑blmf (50 mg) and the inactive ingredients, citric acid monohydrate (0.46 mg), edetate disodium (0.017 mg), polysorbate 80 (0.2 mg), sodium citrate (5.88 mg), and trehalose (68.4 mg). The pH of the reconstituted solution is 6.2."
    },
    {
      "NDCCode": "0404-0173-04",
      "PackageDescription": "1 TUBE in 1 CARTON (0404-0173-04)  / 113.4 g in 1 TUBE",
      "NDC11Code": "00404-0173-04",
      "ProductNDC": "0404-0173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acclean Anti-cavity",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250128",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Henry Schein, Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "1.1",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Acclean Prescription Strength Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.",
      "Description": "Acclean Prescription Strength Anti-Cavity Toothpaste is a self-applied topical fluoride dentifrice containing 1.1% (w/w) sodium fluoride for the prevention and control of dental caries. Acclean Prescription Strength Anti-Cavity Toothpaste with Mint Flavor: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Yellow No. 10, FD&C Blue No. 1, Flavor, Glycerin, Mica (and) Titanium Dioxide, PEG/PPG-116/66 Copolymer, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol."
    },
    {
      "NDCCode": "13630-0173-4",
      "PackageDescription": "156 g in 1 CAN (13630-0173-4) ",
      "NDC11Code": "13630-0173-04",
      "ProductNDC": "13630-0173",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Florida Grown",
      "ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf15",
      "NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190607",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Prime Packaging, Inc.",
      "SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "2; 5; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190607",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "15631-0173-4",
      "PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0173-4) ",
      "NDC11Code": "15631-0173-04",
      "ProductNDC": "15631-0173",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Echinacea Angustifolia",
      "NonProprietaryName": "Echinacea Angustifolia",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151002",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "ECHINACEA ANGUSTIFOLIA",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "37662-0173-4",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0173-4) ",
      "NDC11Code": "37662-0173-04",
      "ProductNDC": "37662-0173",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Carboneum Bromatum",
      "NonProprietaryName": "Carboneum Bromatum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220718",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "TETRABROMOMETHANE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2022-07-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220718",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "38779-0173-4",
      "PackageDescription": "25 g in 1 JAR (38779-0173-4) ",
      "NDC11Code": "38779-0173-04",
      "ProductNDC": "38779-0173",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Acyclovir",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140820",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Medisca Inc.",
      "SubstanceName": "ACYCLOVIR",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-11-14",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "08-SEP-16"
    },
    {
      "NDCCode": "50090-0173-4",
      "PackageDescription": "60 TABLET in 1 BOTTLE (50090-0173-4) ",
      "NDC11Code": "50090-0173-04",
      "ProductNDC": "50090-0173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methocarbamol",
      "NonProprietaryName": "Methocarbamol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040489",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "METHOCARBAMOL",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "51552-0173-4",
      "PackageDescription": "25 g in 1 CONTAINER (51552-0173-4)",
      "NDC11Code": "51552-0173-04",
      "ProductNDC": "51552-0173",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Thymol",
      "DosageFormName": "CRYSTAL",
      "StartMarketingDate": "19980401",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Fagron Inc",
      "SubstanceName": "THYMOL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "71335-0173-4",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0173-4) ",
      "NDC11Code": "71335-0173-04",
      "ProductNDC": "71335-0173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amitriptyline Hydrochloride",
      "NonProprietaryName": "Amitriptyline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141226",
      "EndMarketingDate": "20250430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202446",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150921",
      "EndMarketingDatePackage": "20250430",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
      "Description": "Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum."
    },
    {
      "NDCCode": "49288-0001-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0001-4)",
      "NDC11Code": "49288-0001-04",
      "ProductNDC": "49288-0001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0002-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0002-4)",
      "NDC11Code": "49288-0002-04",
      "ProductNDC": "49288-0002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0003-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0003-4)",
      "NDC11Code": "49288-0003-04",
      "ProductNDC": "49288-0003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alternaria Alternata",
      "NonProprietaryName": "Alternaria Alternata",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA",
      "StrengthNumber": ".025",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0004-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0004-4)",
      "NDC11Code": "49288-0004-04",
      "ProductNDC": "49288-0004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19920413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0017; .0017; .0017; .0017; .0067; .0067; .0067; .0067; .0067; .0067; .0033; .0033; .0022; .0022; .0011; .0011; .0011; .0011; .0011; .0011; .0067; .0067; .0067; .0067; .0067; .0022",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0005-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0005-4)",
      "NDC11Code": "49288-0005-04",
      "ProductNDC": "49288-0005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0008; .0008; .0008; .0008; .0033; .0033; .0033; .0033; .0033; .0033; .0017; .0017; .0011; .0011; .0006; .0006; .0006; .0006; .0006; .0006; .0033; .0033; .0033; .0033; .0033; .0011",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0006-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0006-4)",
      "NDC11Code": "49288-0006-04",
      "ProductNDC": "49288-0006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "A Mold Mixture",
      "NonProprietaryName": "A Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
      "StrengthNumber": ".0004; .0004; .0004; .0004; .0017; .0017; .0017; .0017; .0017; .0017; .0008; .0008; .0006; .0006; .0003; .0003; .0003; .0003; .0003; .0003; .0017; .0017; .0017; .0017; .0017; .0006",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0007-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0007-4)",
      "NDC11Code": "49288-0007-04",
      "ProductNDC": "49288-0007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aspergillus Mixture",
      "NonProprietaryName": "Aspergillus Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS",
      "StrengthNumber": ".0025; .0025; .0025; .0025",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0008-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0008-4)",
      "NDC11Code": "49288-0008-04",
      "ProductNDC": "49288-0008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aspergillus Mixture",
      "NonProprietaryName": "Aspergillus Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS",
      "StrengthNumber": ".0125; .0125; .0125; .0125",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0009-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0009-4)",
      "NDC11Code": "49288-0009-04",
      "ProductNDC": "49288-0009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Almond",
      "NonProprietaryName": "Almond",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALMOND",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0010-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0010-4)",
      "NDC11Code": "49288-0010-04",
      "ProductNDC": "49288-0010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Apple",
      "NonProprietaryName": "Apple",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "APPLE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"49288-0173-4","ProprietaryName":"Standardized Mite, Dermatophagoides Pteronyssinus","NonProprietaryName":"Standardized Mite, Dermatophagoides Pteronyssinus"},{"NDCCode":"49288-0173-3","ProprietaryName":"Standardized Mite, Dermatophagoides Pteronyssinus","NonProprietaryName":"Standardized Mite, Dermatophagoides Pteronyssinus"},{"NDCCode":"49288-0173-5","ProprietaryName":"Standardized Mite, Dermatophagoides Pteronyssinus","NonProprietaryName":"Standardized Mite, Dermatophagoides Pteronyssinus"},{"NDCCode":"0173-0681-01","ProprietaryName":"Relenza","NonProprietaryName":"Zanamivir"},{"NDCCode":"0173-0681-22","ProprietaryName":"Relenza","NonProprietaryName":"Zanamivir"},{"NDCCode":"0173-0783-62","ProprietaryName":"Lovaza","NonProprietaryName":"Omega-3-acid Ethyl Esters"},{"NDCCode":"0173-0822-04","ProprietaryName":"Staxyn","NonProprietaryName":"Vardenafil Hydrochloride"},{"NDCCode":"0173-0822-14","ProprietaryName":"Staxyn","NonProprietaryName":"Vardenafil Hydrochloride"},{"NDCCode":"0173-0866-35","ProprietaryName":"Tanzeum","NonProprietaryName":"Albiglutide"},{"NDCCode":"0173-0867-35","ProprietaryName":"Tanzeum","NonProprietaryName":"Albiglutide"},{"NDCCode":"0173-0904-42","ProprietaryName":"Nucala","NonProprietaryName":"Mepolizumab"},{"NDCCode":"0173-0913-01","ProprietaryName":"Blenrep","NonProprietaryName":"Belantamab Mafodotin"},{"NDCCode":"0404-0173-04","ProprietaryName":"Acclean Anti-cavity","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"13630-0173-4","ProprietaryName":"Florida Grown","NonProprietaryName":"Avobenzone, Octisalate, Octocrylene"},{"NDCCode":"15631-0173-4","ProprietaryName":"Echinacea Angustifolia","NonProprietaryName":"Echinacea Angustifolia"},{"NDCCode":"37662-0173-4","ProprietaryName":"Carboneum Bromatum","NonProprietaryName":"Carboneum Bromatum"},{"NDCCode":"38779-0173-4","NonProprietaryName":"Acyclovir"},{"NDCCode":"50090-0173-4","ProprietaryName":"Methocarbamol","NonProprietaryName":"Methocarbamol"},{"NDCCode":"51552-0173-4","NonProprietaryName":"Thymol"},{"NDCCode":"71335-0173-4","ProprietaryName":"Amitriptyline Hydrochloride","NonProprietaryName":"Amitriptyline Hydrochloride"},{"NDCCode":"49288-0001-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0002-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0003-4","ProprietaryName":"Alternaria Alternata","NonProprietaryName":"Alternaria Alternata"},{"NDCCode":"49288-0004-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0005-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0006-4","ProprietaryName":"A Mold Mixture","NonProprietaryName":"A Mold Mixture"},{"NDCCode":"49288-0007-4","ProprietaryName":"Aspergillus Mixture","NonProprietaryName":"Aspergillus Mixture"},{"NDCCode":"49288-0008-4","ProprietaryName":"Aspergillus Mixture","NonProprietaryName":"Aspergillus Mixture"},{"NDCCode":"49288-0009-4","ProprietaryName":"Almond","NonProprietaryName":"Almond"},{"NDCCode":"49288-0010-4","ProprietaryName":"Apple","NonProprietaryName":"Apple"}]}
                    

<NDCList><NDC><NDCCode>49288-0173-4</NDCCode><ProprietaryName>Standardized Mite, Dermatophagoides Pteronyssinus</ProprietaryName><NonProprietaryName>Standardized Mite, Dermatophagoides Pteronyssinus</NonProprietaryName></NDC><NDC><NDCCode>49288-0173-3</NDCCode><ProprietaryName>Standardized Mite, Dermatophagoides Pteronyssinus</ProprietaryName><NonProprietaryName>Standardized Mite, Dermatophagoides Pteronyssinus</NonProprietaryName></NDC><NDC><NDCCode>49288-0173-5</NDCCode><ProprietaryName>Standardized Mite, Dermatophagoides Pteronyssinus</ProprietaryName><NonProprietaryName>Standardized Mite, Dermatophagoides Pteronyssinus</NonProprietaryName></NDC><NDC><NDCCode>0173-0681-01</NDCCode><ProprietaryName>Relenza</ProprietaryName><NonProprietaryName>Zanamivir</NonProprietaryName></NDC><NDC><NDCCode>0173-0681-22</NDCCode><ProprietaryName>Relenza</ProprietaryName><NonProprietaryName>Zanamivir</NonProprietaryName></NDC><NDC><NDCCode>0173-0783-62</NDCCode><ProprietaryName>Lovaza</ProprietaryName><NonProprietaryName>Omega-3-acid Ethyl Esters</NonProprietaryName></NDC><NDC><NDCCode>0173-0822-04</NDCCode><ProprietaryName>Staxyn</ProprietaryName><NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0173-0822-14</NDCCode><ProprietaryName>Staxyn</ProprietaryName><NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0173-0866-35</NDCCode><ProprietaryName>Tanzeum</ProprietaryName><NonProprietaryName>Albiglutide</NonProprietaryName></NDC><NDC><NDCCode>0173-0867-35</NDCCode><ProprietaryName>Tanzeum</ProprietaryName><NonProprietaryName>Albiglutide</NonProprietaryName></NDC><NDC><NDCCode>0173-0904-42</NDCCode><ProprietaryName>Nucala</ProprietaryName><NonProprietaryName>Mepolizumab</NonProprietaryName></NDC><NDC><NDCCode>0173-0913-01</NDCCode><ProprietaryName>Blenrep</ProprietaryName><NonProprietaryName>Belantamab Mafodotin</NonProprietaryName></NDC><NDC><NDCCode>0404-0173-04</NDCCode><ProprietaryName>Acclean Anti-cavity</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>13630-0173-4</NDCCode><ProprietaryName>Florida Grown</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>15631-0173-4</NDCCode><ProprietaryName>Echinacea Angustifolia</ProprietaryName><NonProprietaryName>Echinacea Angustifolia</NonProprietaryName></NDC><NDC><NDCCode>37662-0173-4</NDCCode><ProprietaryName>Carboneum Bromatum</ProprietaryName><NonProprietaryName>Carboneum Bromatum</NonProprietaryName></NDC><NDC><NDCCode>38779-0173-4</NDCCode><NonProprietaryName>Acyclovir</NonProprietaryName></NDC><NDC><NDCCode>50090-0173-4</NDCCode><ProprietaryName>Methocarbamol</ProprietaryName><NonProprietaryName>Methocarbamol</NonProprietaryName></NDC><NDC><NDCCode>51552-0173-4</NDCCode><NonProprietaryName>Thymol</NonProprietaryName></NDC><NDC><NDCCode>71335-0173-4</NDCCode><ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName><NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49288-0001-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0002-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0003-4</NDCCode><ProprietaryName>Alternaria Alternata</ProprietaryName><NonProprietaryName>Alternaria Alternata</NonProprietaryName></NDC><NDC><NDCCode>49288-0004-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0005-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0006-4</NDCCode><ProprietaryName>A Mold Mixture</ProprietaryName><NonProprietaryName>A Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0007-4</NDCCode><ProprietaryName>Aspergillus Mixture</ProprietaryName><NonProprietaryName>Aspergillus Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0008-4</NDCCode><ProprietaryName>Aspergillus Mixture</ProprietaryName><NonProprietaryName>Aspergillus Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0009-4</NDCCode><ProprietaryName>Almond</ProprietaryName><NonProprietaryName>Almond</NonProprietaryName></NDC><NDC><NDCCode>49288-0010-4</NDCCode><ProprietaryName>Apple</ProprietaryName><NonProprietaryName>Apple</NonProprietaryName></NDC></NDCList>