RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "22840-1634-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-1634-4) ",
      "NDC11Code": "22840-1634-04",
      "ProductNDC": "22840-1634",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Bipolaris Sorokiniana",
      "NonProprietaryName": "Bipolaris Sorokiniana",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19810915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101833",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "COCHLIOBOLUS SATIVUS",
      "StrengthNumber": "20000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19810915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
      "Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
    },
    {
      "NDCCode": "22840-1634-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-1634-2) ",
      "NDC11Code": "22840-1634-02",
      "ProductNDC": "22840-1634",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Bipolaris Sorokiniana",
      "NonProprietaryName": "Bipolaris Sorokiniana",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19810915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101833",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "COCHLIOBOLUS SATIVUS",
      "StrengthNumber": "20000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19810915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
      "Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
    },
    {
      "NDCCode": "36987-1634-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1634-4)",
      "NDC11Code": "36987-1634-04",
      "ProductNDC": "36987-1634",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Coffee",
      "NonProprietaryName": "Coffee",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "ARABICA COFFEE BEAN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "37662-1634-4",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-1634-4) ",
      "NDC11Code": "37662-1634-04",
      "ProductNDC": "37662-1634",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Verbascum Thapsus",
      "NonProprietaryName": "Verbascum Thapsus",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220928",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "VERBASCUM THAPSUS",
      "StrengthNumber": "200",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-09-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220928",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69259-1634-1",
      "PackageDescription": "4 mL in 1 TUBE (69259-1634-1) ",
      "NDC11Code": "69259-1634-01",
      "ProductNDC": "69259-1634",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Your Skin But Better Cc Color Correcting Full Coverage Spf 50",
      "ProprietaryNameSuffix": "Rich",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160809",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "IT COSMETICS, LLC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "9; 6.3",
      "StrengthUnit": "g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160809",
      "SamplePackage": "N",
      "IndicationAndUsage": " Helps prevent sunburn.  If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "71335-1634-4",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71335-1634-4) ",
      "NDC11Code": "71335-1634-04",
      "ProductNDC": "71335-1634",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Finasteride",
      "NonProprietaryName": "Finasteride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100528",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090121",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "FINASTERIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2020-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Finasteride, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1): : 1 Improve symptoms, 2 Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.",
      "Description": "Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17ß)-. The empirical formula of finasteride is C 23H 36N 2O 2 and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, hypromellose, titanium dioxide, magnesium stearate, lauryl macrogolglycerides, FD&C Blue # 2 aluminum lake and polyethylene glycol."
    },
    {
      "NDCCode": "0409-1634-01",
      "PackageDescription": "10 VIAL in 1 CARTON (0409-1634-01)  > 20 mL in 1 VIAL (0409-1634-85) ",
      "NDC11Code": "00409-1634-01",
      "ProductNDC": "0409-1634",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vecuronium Bromide",
      "NonProprietaryName": "Vecuronium Bromide",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20060303",
      "EndMarketingDate": "20230501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075164",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "VECURONIUM BROMIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20060303",
      "EndMarketingDatePackage": "20230501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
      "Description": "Vecuronium bromide for injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-methylpiperidinium bromide, diacetate. Vecuronium bromide for injection is prepared as a solution and lyophilized in its final container. The structural formula is. Its chemical formula is C34H57BrN2O4 with molecular weight 637.73. Vecuronium bromide is supplied as a sterile nonpyrogenic freeze-dried buffered cake of very fine microscopic crystalline particles for intravenous injection only. Each 10 mL vial contains 10 mg vecuronium bromide, 20.75 mg citric acid anhydrous, 16.25 mg sodium phosphate dibasic anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4 (3.5 to 4.5). Each 20 mL vial contains 20 mg of vecuronium bromide, 41.5 mg citric acid anhydrous, 32.5 mg sodium phosphate dibasic anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH of 4 (3.5 to 4.5). Bacteriostatic water for injection, USP when used contains BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS."
    },
    {
      "NDCCode": "51662-1634-1",
      "PackageDescription": "10 mL in 1 VIAL, SINGLE-DOSE (51662-1634-1) ",
      "NDC11Code": "51662-1634-01",
      "ProductNDC": "51662-1634",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Etomidate Injection, Solution",
      "NonProprietaryName": "Etomidate Injection, Solution",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230925",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206126",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "ETOMIDATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-09-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230925",
      "SamplePackage": "N",
      "IndicationAndUsage": "Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS). Intravenous Etomidate Injection is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.",
      "Description": "Etomidate Injection, USP is a sterile, non-pyrogenic, clear, colorless solution, free from visible particles. Each milliliter contains etomidate USP 2 mg, propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0). It is intended for the induction of general anesthesia by intravenous injection. The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1-phenylethyl)-1H-imidazole-5-carboxylate and has the following structural formula:."
    },
    {
      "NDCCode": "22840-0100-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0100-4) ",
      "NDC11Code": "22840-0100-04",
      "ProductNDC": "22840-0100",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Cat Hair Allergenic Extract",
      "NonProprietaryName": "Felis Catus",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19920924",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103397",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "FELIS CATUS DANDER; FELIS CATUS SKIN",
      "StrengthNumber": "5000; 5000",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Animal Skin Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19920924",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Cat Hair Allergenic Extract is indicated for: 1 Skin test diagnosis of patients with a history of allergy to cats., 2 Treatment of cat hair-induced allergic asthma, rhinitis and conjunctivitis. Immunotherapy is indicated when cat allergy is established and the patient cannot avoid exposure to cat allergens.",
      "Description": "GREER Standardized Cat Hair Allergenic Extract is a sterile solution of extracted cat pelt and cat dander. Each vial contains sterile Standardized Cat Hair Allergenic Extract at 10,000 BAU/milliliter or 5,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol volume/volume (preservative). Inactive ingredients include 0.5% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. GREER Standardized Cat Hair Allergenic Extract is labeled in BAU/milliliter. This allergenic extract is not interchangeable with Standardized Cat Pelt Extract or with cat extracts labeled in Allergy Units. The extract is standardized by comparing potency of cat allergen (Fel d 1) units by radial immunodiffusion against a reference standard from the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA). 4,5 An extract with 10.0 to 19.9 Fel d 1 units per milliliter is designated as 10,000 BAU/milliliter by the FDA based on quantitative skin testing. 4,5."
    },
    {
      "NDCCode": "22840-0101-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0101-4) ",
      "NDC11Code": "22840-0101-04",
      "ProductNDC": "22840-0101",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Cat Hair Allergenic Extract",
      "NonProprietaryName": "Felis Catus",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19920924",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103397",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "FELIS CATUS DANDER; FELIS CATUS SKIN",
      "StrengthNumber": "10000; 10000",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Animal Skin Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19920924",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Cat Hair Allergenic Extract is indicated for: 1 Skin test diagnosis of patients with a history of allergy to cats., 2 Treatment of cat hair-induced allergic asthma, rhinitis and conjunctivitis. Immunotherapy is indicated when cat allergy is established and the patient cannot avoid exposure to cat allergens.",
      "Description": "GREER Standardized Cat Hair Allergenic Extract is a sterile solution of extracted cat pelt and cat dander. Each vial contains sterile Standardized Cat Hair Allergenic Extract at 10,000 BAU/milliliter or 5,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol volume/volume (preservative). Inactive ingredients include 0.5% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. GREER Standardized Cat Hair Allergenic Extract is labeled in BAU/milliliter. This allergenic extract is not interchangeable with Standardized Cat Pelt Extract or with cat extracts labeled in Allergy Units. The extract is standardized by comparing potency of cat allergen (Fel d 1) units by radial immunodiffusion against a reference standard from the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA). 4,5 An extract with 10.0 to 19.9 Fel d 1 units per milliliter is designated as 10,000 BAU/milliliter by the FDA based on quantitative skin testing. 4,5."
    },
    {
      "NDCCode": "22840-0200-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0200-4) ",
      "NDC11Code": "22840-0200-04",
      "ProductNDC": "22840-0200",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Bermuda Grass Pollen",
      "NonProprietaryName": "Cynodon Dactylon",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101836",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "CYNODON DACTYLON POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0201-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0201-4) ",
      "NDC11Code": "22840-0201-04",
      "ProductNDC": "22840-0201",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Kentucky (june) Bluegrass Pollen",
      "NonProprietaryName": "Poa Pratensis",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101837",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0202-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0202-4) ",
      "NDC11Code": "22840-0202-04",
      "ProductNDC": "22840-0202",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Kentucky (june) Bluegrass Pollen",
      "NonProprietaryName": "Poa Pratensis",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101837",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0203-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0203-4) ",
      "NDC11Code": "22840-0203-04",
      "ProductNDC": "22840-0203",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Meadow Fescue Pollen",
      "NonProprietaryName": "Festuca Elatior",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101838",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "LOLIUM PRATENSE POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0204-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0204-4) ",
      "NDC11Code": "22840-0204-04",
      "ProductNDC": "22840-0204",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Meadow Fescue Pollen",
      "NonProprietaryName": "Festuca Elatior",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101838",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "LOLIUM PRATENSE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0205-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0205-4) ",
      "NDC11Code": "22840-0205-04",
      "ProductNDC": "22840-0205",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Orchard Grass Pollen",
      "NonProprietaryName": "Dactylis Glomerata",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101839",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DACTYLIS GLOMERATA POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0206-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0206-4) ",
      "NDC11Code": "22840-0206-04",
      "ProductNDC": "22840-0206",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Orchard Grass Pollen",
      "NonProprietaryName": "Dactylis Glomerata",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101839",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DACTYLIS GLOMERATA POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0207-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0207-4) ",
      "NDC11Code": "22840-0207-04",
      "ProductNDC": "22840-0207",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Redtop Pollen",
      "NonProprietaryName": "Agrostis Alba",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101840",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0208-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0208-4) ",
      "NDC11Code": "22840-0208-04",
      "ProductNDC": "22840-0208",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Redtop Pollen",
      "NonProprietaryName": "Agrostis Alba",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101840",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0209-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0209-4) ",
      "NDC11Code": "22840-0209-04",
      "ProductNDC": "22840-0209",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Perennial Ryegrass Pollen",
      "NonProprietaryName": "Lolium Perenne",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101841",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "LOLIUM PERENNE POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0210-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0210-4) ",
      "NDC11Code": "22840-0210-04",
      "ProductNDC": "22840-0210",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Perennial Ryegrass Pollen",
      "NonProprietaryName": "Lolium Perenne",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101841",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "LOLIUM PERENNE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0211-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0211-4) ",
      "NDC11Code": "22840-0211-04",
      "ProductNDC": "22840-0211",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Sweet Vernal Grass Pollen",
      "NonProprietaryName": "Anthoxanthum Odoratum",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101842",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0212-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0212-4) ",
      "NDC11Code": "22840-0212-04",
      "ProductNDC": "22840-0212",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Sweet Vernal Grass Pollen",
      "NonProprietaryName": "Anthoxanthum Odoratum",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101842",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0213-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0213-4) ",
      "NDC11Code": "22840-0213-04",
      "ProductNDC": "22840-0213",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Timothy Pollen",
      "NonProprietaryName": "Phleum Pratense",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101843",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0214-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0214-4) ",
      "NDC11Code": "22840-0214-04",
      "ProductNDC": "22840-0214",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Timothy Pollen",
      "NonProprietaryName": "Phleum Pratense",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101843",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0215-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0215-4) ",
      "NDC11Code": "22840-0215-04",
      "ProductNDC": "22840-0215",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Timothy-orchard Standardized Grass Pollen Mix",
      "NonProprietaryName": "Phleum Pratense And Dactylis Glomerata",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101843",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "50000; 50000",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [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], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0216-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0216-4) ",
      "NDC11Code": "22840-0216-04",
      "ProductNDC": "22840-0216",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "K-o-t Standardized Grass Pollen Mix",
      "NonProprietaryName": "Poa Pratensis, Dactylis Glomerata And Phleum Pratense",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101837",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "3333.333; 3333.333; 3333.333",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0217-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0217-4) ",
      "NDC11Code": "22840-0217-04",
      "ProductNDC": "22840-0217",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "K-o-t Standardized Grass Pollen Mix",
      "NonProprietaryName": "Poa Pratensis, Dactylis Glomerata And Phleum Pratense",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101837",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "33333.333; 33333.333; 33333.333",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0218-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0218-4) ",
      "NDC11Code": "22840-0218-04",
      "ProductNDC": "22840-0218",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "K-o-r-t Standardized Grass Pollen Mix",
      "NonProprietaryName": "Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101837",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "2500; 2500; 2500; 2500",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "22840-0219-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0219-4) ",
      "NDC11Code": "22840-0219-04",
      "ProductNDC": "22840-0219",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "K-o-r-t Standardized Grass Pollen Mix",
      "NonProprietaryName": "Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101837",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "25000; 25000; 25000; 25000",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"22840-1634-4","ProprietaryName":"Bipolaris Sorokiniana","NonProprietaryName":"Bipolaris Sorokiniana"},{"NDCCode":"22840-1634-2","ProprietaryName":"Bipolaris Sorokiniana","NonProprietaryName":"Bipolaris Sorokiniana"},{"NDCCode":"36987-1634-4","ProprietaryName":"Coffee","NonProprietaryName":"Coffee"},{"NDCCode":"37662-1634-4","ProprietaryName":"Verbascum Thapsus","NonProprietaryName":"Verbascum Thapsus"},{"NDCCode":"69259-1634-1","ProprietaryName":"Your Skin But Better Cc Color Correcting Full Coverage Spf 50","NonProprietaryName":"Titanium Dioxide And Zinc Oxide"},{"NDCCode":"71335-1634-4","ProprietaryName":"Finasteride","NonProprietaryName":"Finasteride"},{"NDCCode":"0409-1634-01","ProprietaryName":"Vecuronium Bromide","NonProprietaryName":"Vecuronium Bromide"},{"NDCCode":"51662-1634-1","ProprietaryName":"Etomidate Injection, Solution","NonProprietaryName":"Etomidate Injection, Solution"},{"NDCCode":"22840-0100-4","ProprietaryName":"Standardized Cat Hair Allergenic Extract","NonProprietaryName":"Felis Catus"},{"NDCCode":"22840-0101-4","ProprietaryName":"Standardized Cat Hair Allergenic Extract","NonProprietaryName":"Felis Catus"},{"NDCCode":"22840-0200-4","ProprietaryName":"Standardized Bermuda Grass Pollen","NonProprietaryName":"Cynodon Dactylon"},{"NDCCode":"22840-0201-4","ProprietaryName":"Standardized Kentucky (june) Bluegrass Pollen","NonProprietaryName":"Poa Pratensis"},{"NDCCode":"22840-0202-4","ProprietaryName":"Standardized Kentucky (june) Bluegrass Pollen","NonProprietaryName":"Poa Pratensis"},{"NDCCode":"22840-0203-4","ProprietaryName":"Standardized Meadow Fescue Pollen","NonProprietaryName":"Festuca Elatior"},{"NDCCode":"22840-0204-4","ProprietaryName":"Standardized Meadow Fescue Pollen","NonProprietaryName":"Festuca Elatior"},{"NDCCode":"22840-0205-4","ProprietaryName":"Standardized Orchard Grass Pollen","NonProprietaryName":"Dactylis Glomerata"},{"NDCCode":"22840-0206-4","ProprietaryName":"Standardized Orchard Grass Pollen","NonProprietaryName":"Dactylis Glomerata"},{"NDCCode":"22840-0207-4","ProprietaryName":"Standardized Redtop Pollen","NonProprietaryName":"Agrostis Alba"},{"NDCCode":"22840-0208-4","ProprietaryName":"Standardized Redtop Pollen","NonProprietaryName":"Agrostis Alba"},{"NDCCode":"22840-0209-4","ProprietaryName":"Standardized Perennial Ryegrass Pollen","NonProprietaryName":"Lolium Perenne"},{"NDCCode":"22840-0210-4","ProprietaryName":"Standardized Perennial Ryegrass Pollen","NonProprietaryName":"Lolium Perenne"},{"NDCCode":"22840-0211-4","ProprietaryName":"Standardized Sweet Vernal Grass Pollen","NonProprietaryName":"Anthoxanthum Odoratum"},{"NDCCode":"22840-0212-4","ProprietaryName":"Standardized Sweet Vernal Grass Pollen","NonProprietaryName":"Anthoxanthum Odoratum"},{"NDCCode":"22840-0213-4","ProprietaryName":"Standardized Timothy Pollen","NonProprietaryName":"Phleum Pratense"},{"NDCCode":"22840-0214-4","ProprietaryName":"Standardized Timothy Pollen","NonProprietaryName":"Phleum Pratense"},{"NDCCode":"22840-0215-4","ProprietaryName":"Timothy-orchard Standardized Grass Pollen Mix","NonProprietaryName":"Phleum Pratense And Dactylis Glomerata"},{"NDCCode":"22840-0216-4","ProprietaryName":"K-o-t Standardized Grass Pollen Mix","NonProprietaryName":"Poa Pratensis, Dactylis Glomerata And Phleum Pratense"},{"NDCCode":"22840-0217-4","ProprietaryName":"K-o-t Standardized Grass Pollen Mix","NonProprietaryName":"Poa Pratensis, Dactylis Glomerata And Phleum Pratense"},{"NDCCode":"22840-0218-4","ProprietaryName":"K-o-r-t Standardized Grass Pollen Mix","NonProprietaryName":"Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense"},{"NDCCode":"22840-0219-4","ProprietaryName":"K-o-r-t Standardized Grass Pollen Mix","NonProprietaryName":"Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense"}]}
                    

<NDCList><NDC><NDCCode>22840-1634-4</NDCCode><ProprietaryName>Bipolaris Sorokiniana</ProprietaryName><NonProprietaryName>Bipolaris Sorokiniana</NonProprietaryName></NDC><NDC><NDCCode>22840-1634-2</NDCCode><ProprietaryName>Bipolaris Sorokiniana</ProprietaryName><NonProprietaryName>Bipolaris Sorokiniana</NonProprietaryName></NDC><NDC><NDCCode>36987-1634-4</NDCCode><ProprietaryName>Coffee</ProprietaryName><NonProprietaryName>Coffee</NonProprietaryName></NDC><NDC><NDCCode>37662-1634-4</NDCCode><ProprietaryName>Verbascum Thapsus</ProprietaryName><NonProprietaryName>Verbascum Thapsus</NonProprietaryName></NDC><NDC><NDCCode>69259-1634-1</NDCCode><ProprietaryName>Your Skin But Better Cc Color Correcting Full Coverage Spf 50</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>71335-1634-4</NDCCode><ProprietaryName>Finasteride</ProprietaryName><NonProprietaryName>Finasteride</NonProprietaryName></NDC><NDC><NDCCode>0409-1634-01</NDCCode><ProprietaryName>Vecuronium Bromide</ProprietaryName><NonProprietaryName>Vecuronium Bromide</NonProprietaryName></NDC><NDC><NDCCode>51662-1634-1</NDCCode><ProprietaryName>Etomidate Injection, Solution</ProprietaryName><NonProprietaryName>Etomidate Injection, Solution</NonProprietaryName></NDC><NDC><NDCCode>22840-0100-4</NDCCode><ProprietaryName>Standardized Cat Hair Allergenic Extract</ProprietaryName><NonProprietaryName>Felis Catus</NonProprietaryName></NDC><NDC><NDCCode>22840-0101-4</NDCCode><ProprietaryName>Standardized Cat Hair Allergenic Extract</ProprietaryName><NonProprietaryName>Felis Catus</NonProprietaryName></NDC><NDC><NDCCode>22840-0200-4</NDCCode><ProprietaryName>Standardized Bermuda Grass Pollen</ProprietaryName><NonProprietaryName>Cynodon Dactylon</NonProprietaryName></NDC><NDC><NDCCode>22840-0201-4</NDCCode><ProprietaryName>Standardized Kentucky (june) Bluegrass Pollen</ProprietaryName><NonProprietaryName>Poa Pratensis</NonProprietaryName></NDC><NDC><NDCCode>22840-0202-4</NDCCode><ProprietaryName>Standardized Kentucky (june) Bluegrass Pollen</ProprietaryName><NonProprietaryName>Poa Pratensis</NonProprietaryName></NDC><NDC><NDCCode>22840-0203-4</NDCCode><ProprietaryName>Standardized Meadow Fescue Pollen</ProprietaryName><NonProprietaryName>Festuca Elatior</NonProprietaryName></NDC><NDC><NDCCode>22840-0204-4</NDCCode><ProprietaryName>Standardized Meadow Fescue Pollen</ProprietaryName><NonProprietaryName>Festuca Elatior</NonProprietaryName></NDC><NDC><NDCCode>22840-0205-4</NDCCode><ProprietaryName>Standardized Orchard Grass Pollen</ProprietaryName><NonProprietaryName>Dactylis Glomerata</NonProprietaryName></NDC><NDC><NDCCode>22840-0206-4</NDCCode><ProprietaryName>Standardized Orchard Grass Pollen</ProprietaryName><NonProprietaryName>Dactylis Glomerata</NonProprietaryName></NDC><NDC><NDCCode>22840-0207-4</NDCCode><ProprietaryName>Standardized Redtop Pollen</ProprietaryName><NonProprietaryName>Agrostis Alba</NonProprietaryName></NDC><NDC><NDCCode>22840-0208-4</NDCCode><ProprietaryName>Standardized Redtop Pollen</ProprietaryName><NonProprietaryName>Agrostis Alba</NonProprietaryName></NDC><NDC><NDCCode>22840-0209-4</NDCCode><ProprietaryName>Standardized Perennial Ryegrass Pollen</ProprietaryName><NonProprietaryName>Lolium Perenne</NonProprietaryName></NDC><NDC><NDCCode>22840-0210-4</NDCCode><ProprietaryName>Standardized Perennial Ryegrass Pollen</ProprietaryName><NonProprietaryName>Lolium Perenne</NonProprietaryName></NDC><NDC><NDCCode>22840-0211-4</NDCCode><ProprietaryName>Standardized Sweet Vernal Grass Pollen</ProprietaryName><NonProprietaryName>Anthoxanthum Odoratum</NonProprietaryName></NDC><NDC><NDCCode>22840-0212-4</NDCCode><ProprietaryName>Standardized Sweet Vernal Grass Pollen</ProprietaryName><NonProprietaryName>Anthoxanthum Odoratum</NonProprietaryName></NDC><NDC><NDCCode>22840-0213-4</NDCCode><ProprietaryName>Standardized Timothy Pollen</ProprietaryName><NonProprietaryName>Phleum Pratense</NonProprietaryName></NDC><NDC><NDCCode>22840-0214-4</NDCCode><ProprietaryName>Standardized Timothy Pollen</ProprietaryName><NonProprietaryName>Phleum Pratense</NonProprietaryName></NDC><NDC><NDCCode>22840-0215-4</NDCCode><ProprietaryName>Timothy-orchard Standardized Grass Pollen Mix</ProprietaryName><NonProprietaryName>Phleum Pratense And Dactylis Glomerata</NonProprietaryName></NDC><NDC><NDCCode>22840-0216-4</NDCCode><ProprietaryName>K-o-t Standardized Grass Pollen Mix</ProprietaryName><NonProprietaryName>Poa Pratensis, Dactylis Glomerata And Phleum Pratense</NonProprietaryName></NDC><NDC><NDCCode>22840-0217-4</NDCCode><ProprietaryName>K-o-t Standardized Grass Pollen Mix</ProprietaryName><NonProprietaryName>Poa Pratensis, Dactylis Glomerata And Phleum Pratense</NonProprietaryName></NDC><NDC><NDCCode>22840-0218-4</NDCCode><ProprietaryName>K-o-r-t Standardized Grass Pollen Mix</ProprietaryName><NonProprietaryName>Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense</NonProprietaryName></NDC><NDC><NDCCode>22840-0219-4</NDCCode><ProprietaryName>K-o-r-t Standardized Grass Pollen Mix</ProprietaryName><NonProprietaryName>Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense</NonProprietaryName></NDC></NDCList>