RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "65044-6516-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-6516-5) ",
      "NDC11Code": "65044-6516-05",
      "ProductNDC": "65044-6516",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Insects Whole Body, Fire Ant Mix",
      "NonProprietaryName": "Insects Whole Body, Fire Ant Mix",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19410419",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103888",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "SOLENOPSIS RICHTERI; SOLENOPSIS INVICTA",
      "StrengthNumber": "500; 500",
      "StrengthUnit": "[PNU]/mL; [PNU]/mL",
      "Pharm_Classes": "Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Ant Venoms [CS],Allergens [CS],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Ant Venoms [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19410419",
      "SamplePackage": "N",
      "IndicationAndUsage": "Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15. In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY. Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.",
      "Description": "Extracts for intradermal testing are supplied in sterile multi-dose vials containing, in addition to the extract allergens and antigens, 0.5% sodium chloride, 0.275% sodium bicarbonate, up to 2% glycerin, 2.5% glycerin for AP products, and, as preservative, 0.4% phenol. The strength of these extracts may be expressed in terms of:. 1. Weight to Volume (w/v) 2. Protein Nitrogen Units/mL (PNU/mL)3. Allergy Units/mL (AU/mL)4. Bioequivalent Allergy Units/mL (BAU/mL)5. Concentrate: 1 Weight to volume (w/v). For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted material will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. In contrast to this, AP (acetone precipitated) extracts, if present, are prepared by reconstituting dry allergenically active concentrates produced by a precipitation process from extracts of raw materials. For those AP extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution., 2 Protein Nitrogen Units per mL (PNU/mL). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, PNU contents of extracts from different manufacturers are not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract., 3 Allergy Units per mL (AU/mL). The potency of standardized AP and regular extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to the reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration., 4 Bioequivalent Allergy Units per mL(BAU/mL). When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method14 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects., 5 Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength."
    },
    {
      "NDCCode": "0268-6516-06",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (0268-6516-06) ",
      "NDC11Code": "00268-6516-06",
      "ProductNDC": "0268-6516",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Chaetomium Globosum",
      "NonProprietaryName": "Chaetomium Globosum",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "CHAETOMIUM GLOBOSUM",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/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": "Deprecated",
      "LastUpdate": "2023-05-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19650101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0904-6516-61",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-6516-61)  > 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00904-6516-61",
      "ProductNDC": "0904-6516",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Meclizine Hydrochloride",
      "NonProprietaryName": "Meclizine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100212",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201451",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "MECLIZINE HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20100212",
      "SamplePackage": "N",
      "IndicationAndUsage": "Management of nausea and vomiting, and dizziness associated with motion sickness.",
      "Description": "Chemically, meclizine HCl, USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&C Yellow #10 Aluminum Lake."
    },
    {
      "NDCCode": "65044-0020-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0020-1) ",
      "NDC11Code": "65044-0020-01",
      "ProductNDC": "65044-0020",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "StartMarketingDate": "20161019",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2026-06-03",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19-OCT-16"
    },
    {
      "NDCCode": "65044-0040-1",
      "PackageDescription": "1.5 mL in 1 VIAL, GLASS (65044-0040-1) ",
      "NDC11Code": "65044-0040-01",
      "ProductNDC": "65044-0040",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Perflutren",
      "DosageFormName": "INJECTION, SUSPENSION",
      "StartMarketingDate": "20130205",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "PERFLUTREN",
      "StrengthNumber": "6.52",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-05",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "05-FEB-13"
    },
    {
      "NDCCode": "65044-0537-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0537-1) ",
      "NDC11Code": "65044-0537-01",
      "ProductNDC": "65044-0537",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Bermuda Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Bermuda Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103872",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0538-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0538-5) ",
      "NDC11Code": "65044-0538-05",
      "ProductNDC": "65044-0538",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Bermuda Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Bermuda Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103872",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "CYNODON DACTYLON POLLEN",
      "StrengthNumber": "100",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0545-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0545-1) ",
      "NDC11Code": "65044-0545-01",
      "ProductNDC": "65044-0545",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
      "NonProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103873",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0546-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0546-1) ",
      "NDC11Code": "65044-0546-01",
      "ProductNDC": "65044-0546",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
      "NonProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103873",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0547-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0547-5) ",
      "NDC11Code": "65044-0547-05",
      "ProductNDC": "65044-0547",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
      "NonProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103873",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "POA PRATENSIS POLLEN",
      "StrengthNumber": "100",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0548-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0548-5) ",
      "NDC11Code": "65044-0548-05",
      "ProductNDC": "65044-0548",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
      "NonProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103873",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "POA PRATENSIS POLLEN",
      "StrengthNumber": "1000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0611-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0611-1) ",
      "NDC11Code": "65044-0611-01",
      "ProductNDC": "65044-0611",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
      "NonProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103874",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0612-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0612-1) ",
      "NDC11Code": "65044-0612-01",
      "ProductNDC": "65044-0612",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
      "NonProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103874",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0613-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0613-5) ",
      "NDC11Code": "65044-0613-05",
      "ProductNDC": "65044-0613",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
      "NonProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103874",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "FESTUCA PRATENSIS POLLEN",
      "StrengthNumber": "100",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0614-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0614-5) ",
      "NDC11Code": "65044-0614-05",
      "ProductNDC": "65044-0614",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
      "NonProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103874",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "FESTUCA PRATENSIS POLLEN",
      "StrengthNumber": "1000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0718-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0718-1) ",
      "NDC11Code": "65044-0718-01",
      "ProductNDC": "65044-0718",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Orchard Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Orchard Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103875",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0719-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0719-1) ",
      "NDC11Code": "65044-0719-01",
      "ProductNDC": "65044-0719",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Orchard Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Orchard Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103875",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0720-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0720-5) ",
      "NDC11Code": "65044-0720-05",
      "ProductNDC": "65044-0720",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Orchard Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Orchard Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103875",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "DACTYLIS GLOMERATA POLLEN",
      "StrengthNumber": "100",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0721-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0721-5) ",
      "NDC11Code": "65044-0721-05",
      "ProductNDC": "65044-0721",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Orchard Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Orchard Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103875",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "DACTYLIS GLOMERATA POLLEN",
      "StrengthNumber": "1000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0777-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0777-1) ",
      "NDC11Code": "65044-0777-01",
      "ProductNDC": "65044-0777",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Redtop",
      "NonProprietaryName": "Standardized Grass Pollen, Redtop",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103876",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0778-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0778-1) ",
      "NDC11Code": "65044-0778-01",
      "ProductNDC": "65044-0778",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Redtop",
      "NonProprietaryName": "Standardized Grass Pollen, Redtop",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103876",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0779-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0779-5) ",
      "NDC11Code": "65044-0779-05",
      "ProductNDC": "65044-0779",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Redtop",
      "NonProprietaryName": "Standardized Grass Pollen, Redtop",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103876",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN",
      "StrengthNumber": "100",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0780-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0780-5) ",
      "NDC11Code": "65044-0780-05",
      "ProductNDC": "65044-0780",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Redtop",
      "NonProprietaryName": "Standardized Grass Pollen, Redtop",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103876",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN",
      "StrengthNumber": "1000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0787-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0787-1) ",
      "NDC11Code": "65044-0787-01",
      "ProductNDC": "65044-0787",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Ryegrass",
      "NonProprietaryName": "Standardized Grass Pollen, Ryegrass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103877",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0788-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0788-1) ",
      "NDC11Code": "65044-0788-01",
      "ProductNDC": "65044-0788",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Ryegrass",
      "NonProprietaryName": "Standardized Grass Pollen, Ryegrass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103877",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0789-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0789-5) ",
      "NDC11Code": "65044-0789-05",
      "ProductNDC": "65044-0789",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Ryegrass",
      "NonProprietaryName": "Standardized Grass Pollen, Ryegrass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103877",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "LOLIUM PERENNE POLLEN",
      "StrengthNumber": "100",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0790-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0790-5) ",
      "NDC11Code": "65044-0790-05",
      "ProductNDC": "65044-0790",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Ryegrass",
      "NonProprietaryName": "Standardized Grass Pollen, Ryegrass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103877",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "LOLIUM PERENNE POLLEN",
      "StrengthNumber": "1000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    },
    {
      "NDCCode": "65044-0825-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0825-1) ",
      "NDC11Code": "65044-0825-01",
      "ProductNDC": "65044-0825",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103878",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0826-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-0826-1) ",
      "NDC11Code": "65044-0826-01",
      "ProductNDC": "65044-0826",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103878",
      "LabelerName": "Jubilant HollisterStier LLC",
      "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": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer.  Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "65044-0827-5",
      "PackageDescription": "5 mL in 1 VIAL (65044-0827-5) ",
      "NDC11Code": "65044-0827-05",
      "ProductNDC": "65044-0827",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
      "NonProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103878",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
      "StrengthNumber": "100",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N",
      "IndicationAndUsage": "16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.",
      "Description": "The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the \"Concentrate\" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"65044-6516-5","ProprietaryName":"Insects Whole Body, Fire Ant Mix","NonProprietaryName":"Insects Whole Body, Fire Ant Mix"},{"NDCCode":"0268-6516-06","ProprietaryName":"Chaetomium Globosum","NonProprietaryName":"Chaetomium Globosum"},{"NDCCode":"0904-6516-61","ProprietaryName":"Meclizine Hydrochloride","NonProprietaryName":"Meclizine"},{"NDCCode":"65044-0020-1","NonProprietaryName":"Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate"},{"NDCCode":"65044-0040-1","NonProprietaryName":"Perflutren"},{"NDCCode":"65044-0537-1","ProprietaryName":"Standardized Grass Pollen, Bermuda Grass","NonProprietaryName":"Standardized Grass Pollen, Bermuda Grass"},{"NDCCode":"65044-0538-5","ProprietaryName":"Standardized Grass Pollen, Bermuda Grass","NonProprietaryName":"Standardized Grass Pollen, Bermuda Grass"},{"NDCCode":"65044-0545-1","ProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June","NonProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June"},{"NDCCode":"65044-0546-1","ProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June","NonProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June"},{"NDCCode":"65044-0547-5","ProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June","NonProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June"},{"NDCCode":"65044-0548-5","ProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June","NonProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June"},{"NDCCode":"65044-0611-1","ProprietaryName":"Standardized Grass Pollen, Fescue, Meadow","NonProprietaryName":"Standardized Grass Pollen, Fescue, Meadow"},{"NDCCode":"65044-0612-1","ProprietaryName":"Standardized Grass Pollen, Fescue, Meadow","NonProprietaryName":"Standardized Grass Pollen, Fescue, Meadow"},{"NDCCode":"65044-0613-5","ProprietaryName":"Standardized Grass Pollen, Fescue, Meadow","NonProprietaryName":"Standardized Grass Pollen, Fescue, Meadow"},{"NDCCode":"65044-0614-5","ProprietaryName":"Standardized Grass Pollen, Fescue, Meadow","NonProprietaryName":"Standardized Grass Pollen, Fescue, Meadow"},{"NDCCode":"65044-0718-1","ProprietaryName":"Standardized Grass Pollen, Orchard Grass","NonProprietaryName":"Standardized Grass Pollen, Orchard Grass"},{"NDCCode":"65044-0719-1","ProprietaryName":"Standardized Grass Pollen, Orchard Grass","NonProprietaryName":"Standardized Grass Pollen, Orchard Grass"},{"NDCCode":"65044-0720-5","ProprietaryName":"Standardized Grass Pollen, Orchard Grass","NonProprietaryName":"Standardized Grass Pollen, Orchard Grass"},{"NDCCode":"65044-0721-5","ProprietaryName":"Standardized Grass Pollen, Orchard Grass","NonProprietaryName":"Standardized Grass Pollen, Orchard Grass"},{"NDCCode":"65044-0777-1","ProprietaryName":"Standardized Grass Pollen, Redtop","NonProprietaryName":"Standardized Grass Pollen, Redtop"},{"NDCCode":"65044-0778-1","ProprietaryName":"Standardized Grass Pollen, Redtop","NonProprietaryName":"Standardized Grass Pollen, Redtop"},{"NDCCode":"65044-0779-5","ProprietaryName":"Standardized Grass Pollen, Redtop","NonProprietaryName":"Standardized Grass Pollen, Redtop"},{"NDCCode":"65044-0780-5","ProprietaryName":"Standardized Grass Pollen, Redtop","NonProprietaryName":"Standardized Grass Pollen, Redtop"},{"NDCCode":"65044-0787-1","ProprietaryName":"Standardized Grass Pollen, Ryegrass","NonProprietaryName":"Standardized Grass Pollen, Ryegrass"},{"NDCCode":"65044-0788-1","ProprietaryName":"Standardized Grass Pollen, Ryegrass","NonProprietaryName":"Standardized Grass Pollen, Ryegrass"},{"NDCCode":"65044-0789-5","ProprietaryName":"Standardized Grass Pollen, Ryegrass","NonProprietaryName":"Standardized Grass Pollen, Ryegrass"},{"NDCCode":"65044-0790-5","ProprietaryName":"Standardized Grass Pollen, Ryegrass","NonProprietaryName":"Standardized Grass Pollen, Ryegrass"},{"NDCCode":"65044-0825-1","ProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass","NonProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass"},{"NDCCode":"65044-0826-1","ProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass","NonProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass"},{"NDCCode":"65044-0827-5","ProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass","NonProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass"}]}
                    

<NDCList><NDC><NDCCode>65044-6516-5</NDCCode><ProprietaryName>Insects Whole Body, Fire Ant Mix</ProprietaryName><NonProprietaryName>Insects Whole Body, Fire Ant Mix</NonProprietaryName></NDC><NDC><NDCCode>0268-6516-06</NDCCode><ProprietaryName>Chaetomium Globosum</ProprietaryName><NonProprietaryName>Chaetomium Globosum</NonProprietaryName></NDC><NDC><NDCCode>0904-6516-61</NDCCode><ProprietaryName>Meclizine Hydrochloride</ProprietaryName><NonProprietaryName>Meclizine</NonProprietaryName></NDC><NDC><NDCCode>65044-0020-1</NDCCode><NonProprietaryName>Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate</NonProprietaryName></NDC><NDC><NDCCode>65044-0040-1</NDCCode><NonProprietaryName>Perflutren</NonProprietaryName></NDC><NDC><NDCCode>65044-0537-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Bermuda Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bermuda Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0538-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Bermuda Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bermuda Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0545-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</NonProprietaryName></NDC><NDC><NDCCode>65044-0546-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</NonProprietaryName></NDC><NDC><NDCCode>65044-0547-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</NonProprietaryName></NDC><NDC><NDCCode>65044-0548-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</NonProprietaryName></NDC><NDC><NDCCode>65044-0611-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Fescue, Meadow</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Fescue, Meadow</NonProprietaryName></NDC><NDC><NDCCode>65044-0612-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Fescue, Meadow</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Fescue, Meadow</NonProprietaryName></NDC><NDC><NDCCode>65044-0613-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Fescue, Meadow</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Fescue, Meadow</NonProprietaryName></NDC><NDC><NDCCode>65044-0614-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Fescue, Meadow</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Fescue, Meadow</NonProprietaryName></NDC><NDC><NDCCode>65044-0718-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Orchard Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Orchard Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0719-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Orchard Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Orchard Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0720-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Orchard Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Orchard Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0721-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Orchard Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Orchard Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0777-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Redtop</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Redtop</NonProprietaryName></NDC><NDC><NDCCode>65044-0778-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Redtop</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Redtop</NonProprietaryName></NDC><NDC><NDCCode>65044-0779-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Redtop</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Redtop</NonProprietaryName></NDC><NDC><NDCCode>65044-0780-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Redtop</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Redtop</NonProprietaryName></NDC><NDC><NDCCode>65044-0787-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName></NDC><NDC><NDCCode>65044-0788-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName></NDC><NDC><NDCCode>65044-0789-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName></NDC><NDC><NDCCode>65044-0790-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName></NDC><NDC><NDCCode>65044-0825-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0826-1</NDCCode><ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0827-5</NDCCode><ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName></NDC></NDCList>