RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "22840-1657-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-1657-4) ",
      "NDC11Code": "22840-1657-04",
      "ProductNDC": "22840-1657",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Cladosporium Herbarum",
      "NonProprietaryName": "Cladosporium Herbarum",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19810915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101833",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "CLADOSPORIUM HERBARUM",
      "StrengthNumber": "40000",
      "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": "36987-1657-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1657-4)",
      "NDC11Code": "36987-1657-04",
      "ProductNDC": "36987-1657",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Orange Pekoe Tea",
      "NonProprietaryName": "Orange Pekoe Tea",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "TEA LEAF",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant 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": "38779-1657-4",
      "PackageDescription": "25 g in 1 VIAL, GLASS (38779-1657-4) ",
      "NDC11Code": "38779-1657-04",
      "ProductNDC": "38779-1657",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20121213",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Medisca Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-11-21",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "13-DEC-12"
    },
    {
      "NDCCode": "69238-1657-4",
      "PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-4)  / 4 mL in 1 BOTTLE, WITH APPLICATOR",
      "NDC11Code": "69238-1657-04",
      "ProductNDC": "69238-1657",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tavaborole",
      "NonProprietaryName": "Tavaborole",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201128",
      "EndMarketingDate": "20260831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212256",
      "LabelerName": "Amneal Pharmaceuticals NY LLC",
      "SubstanceName": "TAVABOROLE",
      "StrengthNumber": "43.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20201128",
      "EndMarketingDatePackage": "20260831",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tavaborole topical solution is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.",
      "Description": "Tavaborole topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula is C7H6BFO2, the molecular weight is 151.93 and the structural formula is. Tavaborole is a white to off-white powder. It is slightly soluble in water and freely soluble in ethanol and propylene glycol. Each mL of tavaborole topical solution contains 43.5 mg of tavaborole. Inactive ingredients include alcohol (73.70% v/v), edetate calcium disodium, and propylene glycol."
    },
    {
      "NDCCode": "0115-1657-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0115-1657-01) ",
      "NDC11Code": "00115-1657-01",
      "ProductNDC": "0115-1657",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nabumetone",
      "NonProprietaryName": "Nabumetone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075189",
      "LabelerName": "Amneal Pharmaceuticals of New York LLC",
      "SubstanceName": "NABUMETONE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20010820",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of Nabumetone Tablets USP and other treatment options before deciding to use Nabumetone Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone Tablets USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
      "Description": "Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone, USP is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg or 750 mg of nabumetone, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, sodium starch glycolate, talc, and titanium dioxide. The 750 mg tablets also contain black iron oxide, red iron oxide, and yellow iron oxide."
    },
    {
      "NDCCode": "0115-1657-03",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (0115-1657-03) ",
      "NDC11Code": "00115-1657-03",
      "ProductNDC": "0115-1657",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nabumetone",
      "NonProprietaryName": "Nabumetone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20010820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075189",
      "LabelerName": "Amneal Pharmaceuticals of New York LLC",
      "SubstanceName": "NABUMETONE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20010820",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of Nabumetone Tablets USP and other treatment options before deciding to use Nabumetone Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone Tablets USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
      "Description": "Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone, USP is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg or 750 mg of nabumetone, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, sodium starch glycolate, talc, and titanium dioxide. The 750 mg tablets also contain black iron oxide, red iron oxide, and yellow iron oxide."
    },
    {
      "NDCCode": "0378-1657-77",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1657-77) ",
      "NDC11Code": "00378-1657-77",
      "ProductNDC": "0378-1657",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sildenafil",
      "NonProprietaryName": "Sildinafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121109",
      "EndMarketingDate": "20240229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201150",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20121109",
      "EndMarketingDatePackage": "20240229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adults. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric Patients (1 to 17 Years old). Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies (14)].",
      "Description": "Sildenafil tablets USP, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.70. Sildenafil Tablets: Sildenafil tablets are formulated as blue, film-coated, oval, unscored tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "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."
    },
    {
      "NDCCode": "22840-0220-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0220-4) ",
      "NDC11Code": "22840-0220-04",
      "ProductNDC": "22840-0220",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "K-o-r-t And Sweet Vernal Standardized Grass Pollen Mix",
      "NonProprietaryName": "Poa Pratensis, Dactylis Glomerata, Agrostis Alba, Phleum Pratense, And Anthoxanthum Odoratum",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101837",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "2000; 2000; 2000; 2000; 2000",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], 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], 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":"22840-1657-4","ProprietaryName":"Cladosporium Herbarum","NonProprietaryName":"Cladosporium Herbarum"},{"NDCCode":"36987-1657-4","ProprietaryName":"Orange Pekoe Tea","NonProprietaryName":"Orange Pekoe Tea"},{"NDCCode":"38779-1657-4","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"69238-1657-4","ProprietaryName":"Tavaborole","NonProprietaryName":"Tavaborole"},{"NDCCode":"0115-1657-01","ProprietaryName":"Nabumetone","NonProprietaryName":"Nabumetone"},{"NDCCode":"0115-1657-03","ProprietaryName":"Nabumetone","NonProprietaryName":"Nabumetone"},{"NDCCode":"0378-1657-77","ProprietaryName":"Sildenafil","NonProprietaryName":"Sildinafil"},{"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"},{"NDCCode":"22840-0220-4","ProprietaryName":"K-o-r-t And Sweet Vernal Standardized Grass Pollen Mix","NonProprietaryName":"Poa Pratensis, Dactylis Glomerata, Agrostis Alba, Phleum Pratense, And Anthoxanthum Odoratum"}]}
                    

<NDCList><NDC><NDCCode>22840-1657-4</NDCCode><ProprietaryName>Cladosporium Herbarum</ProprietaryName><NonProprietaryName>Cladosporium Herbarum</NonProprietaryName></NDC><NDC><NDCCode>36987-1657-4</NDCCode><ProprietaryName>Orange Pekoe Tea</ProprietaryName><NonProprietaryName>Orange Pekoe Tea</NonProprietaryName></NDC><NDC><NDCCode>38779-1657-4</NDCCode><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>69238-1657-4</NDCCode><ProprietaryName>Tavaborole</ProprietaryName><NonProprietaryName>Tavaborole</NonProprietaryName></NDC><NDC><NDCCode>0115-1657-01</NDCCode><ProprietaryName>Nabumetone</ProprietaryName><NonProprietaryName>Nabumetone</NonProprietaryName></NDC><NDC><NDCCode>0115-1657-03</NDCCode><ProprietaryName>Nabumetone</ProprietaryName><NonProprietaryName>Nabumetone</NonProprietaryName></NDC><NDC><NDCCode>0378-1657-77</NDCCode><ProprietaryName>Sildenafil</ProprietaryName><NonProprietaryName>Sildinafil</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><NDC><NDCCode>22840-0220-4</NDCCode><ProprietaryName>K-o-r-t And Sweet Vernal Standardized Grass Pollen Mix</ProprietaryName><NonProprietaryName>Poa Pratensis, Dactylis Glomerata, Agrostis Alba, Phleum Pratense, And Anthoxanthum Odoratum</NonProprietaryName></NDC></NDCList>