RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "22840-9477-1",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (22840-9477-1) ",
      "NDC11Code": "22840-9477-01",
      "ProductNDC": "22840-9477",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Western 10 Tree Pollen Mix",
      "NonProprietaryName": "Acacia Dealbata, Acer Negundo, Populus Fremontii, Olea Europaea, Ulmus Pumila, Betula Occidentalis, Juniperus Occidentalis, Platanus Racemosa, Quercus Garryana And Morus Alba",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19810915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101833",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "ACACIA DEALBATA POLLEN; OLEA EUROPAEA POLLEN; ULMUS PUMILA POLLEN; ACER NEGUNDO POLLEN; POPULUS FREMONTII POLLEN; BETULA OCCIDENTALIS POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; PLATANUS RACEMOSA POLLEN; QUERCUS GARRYANA POLLEN; MORUS ALBA POLLEN",
      "StrengthNumber": ".0001; .0001; .0001; .0001; .0001; .0001; .0001; .0001; .0001; .0001",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19810915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
      "Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
    },
    {
      "NDCCode": "0093-9477-53",
      "PackageDescription": "50 TABLET in 1 BOTTLE (0093-9477-53) ",
      "NDC11Code": "00093-9477-53",
      "ProductNDC": "0093-9477",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glyburide",
      "NonProprietaryName": "Glyburide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19840501",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA017532",
      "LabelerName": "TEVA Pharmaceuticals USA Inc",
      "SubstanceName": "GLYBURIDE",
      "StrengthNumber": "1.25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-08-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19840501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea class. It is a white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Glyburide tablets USP contain the active ingredient glyburide and the following inactive ingredients: dibasic calcium phosphate USP, magnesium stearate NF, microcrystalline cellulose NF, sodium alginate NF, talc USP. Glyburide 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Glyburide 5 mg tablets USP also contain FD&C Blue #1 Aluminum Lake. Chemically, Glyburide is identified as 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea. The CAS Registry Number is 10238-21-8. The structural formula is. The molecular weight is 493.99. The aqueous solubility of Glyburide increases with pH as a result of salt formation."
    },
    {
      "NDCCode": "0143-9477-10",
      "PackageDescription": "10 VIAL in 1 CARTON (0143-9477-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9477-01) ",
      "NDC11Code": "00143-9477-10",
      "ProductNDC": "0143-9477",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefepime Hydrochloride",
      "NonProprietaryName": "Cefepime Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20251031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214402",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "CEFEPIME HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251031",
      "SamplePackage": "N",
      "Description": "Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber."
    },
    {
      "NDCCode": "10157-9477-1",
      "PackageDescription": "9.75 mL in 1 BOTTLE, WITH APPLICATOR (10157-9477-1) ",
      "NDC11Code": "10157-9477-01",
      "ProductNDC": "10157-9477",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kank-a",
      "ProprietaryNameSuffix": "Mouth Pain",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "LIQUID",
      "RouteName": "BUCCAL",
      "StartMarketingDate": "20111201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Blistex Inc.",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20111201",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums."
    },
    {
      "NDCCode": "55154-9477-9",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (55154-9477-9)  > 5 TABLET in 1 BLISTER PACK",
      "NDC11Code": "55154-9477-09",
      "ProductNDC": "55154-9477",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Primidone",
      "NonProprietaryName": "Primidone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010524",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084903",
      "LabelerName": "Cardinal Health",
      "SubstanceName": "PRIMIDONE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2016-02-26"
    },
    {
      "NDCCode": "63629-9477-1",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9477-1) ",
      "NDC11Code": "63629-9477-01",
      "ProductNDC": "63629-9477",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Extended-release",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190822",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210651",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
      "StrengthNumber": "2.5; 2.5; 2.5; 2.5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1): 1 Children (ages 6 to 12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14), 2 Adolescents (ages 13 to 17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14), 3 Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. (14).",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a once daily extended-release, single-entity amphetamine product. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules combine the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended release capsules are a dose proportional composition using a multi-layer fluid bed bead coating process, followed by encapsulation using hard gelatin capsules. The dosage utilizes a bead that is coated with an extended-release drug layer, that is then coated with an enteric polymer to control drug release, and finally coated with an immediate-release drug layer."
    },
    {
      "NDCCode": "22840-0033-6",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0033-6) ",
      "NDC11Code": "22840-0033-06",
      "ProductNDC": "22840-0033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
      "NonProprietaryName": "Dermatophagoides Farinae",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19870202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101834",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "5000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19870202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0033-8",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0033-8) ",
      "NDC11Code": "22840-0033-08",
      "ProductNDC": "22840-0033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
      "NonProprietaryName": "Dermatophagoides Farinae",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19870202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101834",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "5000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "19870202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0033-9",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0033-9) ",
      "NDC11Code": "22840-0033-09",
      "ProductNDC": "22840-0033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
      "NonProprietaryName": "Dermatophagoides Farinae",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19870202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101834",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "5000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19870202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0034-3",
      "PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-0034-3) ",
      "NDC11Code": "22840-0034-03",
      "ProductNDC": "22840-0034",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
      "NonProprietaryName": "Dermatophagoides Farinae",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19870202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101834",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19870202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0034-6",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0034-6) ",
      "NDC11Code": "22840-0034-06",
      "ProductNDC": "22840-0034",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
      "NonProprietaryName": "Dermatophagoides Farinae",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19870202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101834",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
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      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0034-8",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0034-8) ",
      "NDC11Code": "22840-0034-08",
      "ProductNDC": "22840-0034",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
      "NonProprietaryName": "Dermatophagoides Farinae",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19870202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101834",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
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      "LastUpdate": "2025-02-11",
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      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0034-9",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0034-9) ",
      "NDC11Code": "22840-0034-09",
      "ProductNDC": "22840-0034",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
      "NonProprietaryName": "Dermatophagoides Farinae",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19870202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101834",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19870202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0035-6",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0035-6) ",
      "NDC11Code": "22840-0035-06",
      "ProductNDC": "22840-0035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19890627",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101835",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "5000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
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      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19890627",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0035-8",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0035-8) ",
      "NDC11Code": "22840-0035-08",
      "ProductNDC": "22840-0035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19890627",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101835",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
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      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
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      "LastUpdate": "2025-02-11",
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      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0035-9",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0035-9) ",
      "NDC11Code": "22840-0035-09",
      "ProductNDC": "22840-0035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19890627",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101835",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "5000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
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      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0036-3",
      "PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-0036-3) ",
      "NDC11Code": "22840-0036-03",
      "ProductNDC": "22840-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19890627",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101835",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
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      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19890627",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0036-6",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0036-6) ",
      "NDC11Code": "22840-0036-06",
      "ProductNDC": "22840-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19890627",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101835",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
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      "ListingRecordCertifiedThrough": "20261231",
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      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0036-8",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0036-8) ",
      "NDC11Code": "22840-0036-08",
      "ProductNDC": "22840-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19890627",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101835",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "19890627",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0036-9",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0036-9) ",
      "NDC11Code": "22840-0036-09",
      "ProductNDC": "22840-0036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
      "DosageFormName": "CONCENTRATE",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19890627",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101835",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19890627",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0037-3",
      "PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-0037-3) ",
      "NDC11Code": "22840-0037-03",
      "ProductNDC": "22840-0037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Mix Dermatophagoides Farinae And Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Farinae And Dermatophagoides Pteronyssinus",
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      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0037-8) ",
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      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0037-9) ",
      "NDC11Code": "22840-0037-09",
      "ProductNDC": "22840-0037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Mix Dermatophagoides Farinae And Dermatophagoides Pteronyssinus",
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      "SubstanceName": "DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "5000; 5000",
      "StrengthUnit": "[AU]/mL; [AU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]",
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      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0038-6",
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      "NDC11Code": "22840-0038-06",
      "ProductNDC": "22840-0038",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
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      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
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      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
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      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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    {
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      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0038-9",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0038-9) ",
      "NDC11Code": "22840-0038-09",
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      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0039-6",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0039-6) ",
      "NDC11Code": "22840-0039-06",
      "ProductNDC": "22840-0039",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
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      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0039-8",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0039-8) ",
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      "ProductNDC": "22840-0039",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    },
    {
      "NDCCode": "22840-0039-9",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0039-9) ",
      "NDC11Code": "22840-0039-09",
      "ProductNDC": "22840-0039",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
      "NonProprietaryName": "Dermatophagoides Pteronyssinus",
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      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
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      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100203",
      "SamplePackage": "N",
      "IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
      "Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
    }
  ]
}
                    

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