RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "65044-2098-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-2098-2) ",
      "NDC11Code": "65044-2098-02",
      "ProductNDC": "65044-2098",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Pollens - Trees, Pecan Carya Carya Illinoensis",
      "NonProprietaryName": "Pecan Carya Carya Illinoensis",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19410419",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103888",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "CARYA ILLINOINENSIS POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/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]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19410419",
      "SamplePackage": "N",
      "IndicationAndUsage": "NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.",
      "Description": "Non-standardized allergenic extracts are labeled “No U.S.  Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution.  Product concentrations vary based on the source.  Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents:  casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements.  Acetone and ether may be used as drying and de-fatting agents.  Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas."
    },
    {
      "NDCCode": "65044-2098-3",
      "PackageDescription": "30 mL in 1 VIAL (65044-2098-3) ",
      "NDC11Code": "65044-2098-03",
      "ProductNDC": "65044-2098",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Pollens - Trees, Pecan Carya Carya Illinoensis",
      "NonProprietaryName": "Pecan Carya Carya Illinoensis",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19410419",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103888",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "CARYA ILLINOINENSIS POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/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]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19410419",
      "SamplePackage": "N",
      "IndicationAndUsage": "NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.",
      "Description": "Non-standardized allergenic extracts are labeled “No U.S.  Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution.  Product concentrations vary based on the source.  Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents:  casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements.  Acetone and ether may be used as drying and de-fatting agents.  Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas."
    },
    {
      "NDCCode": "65044-2098-4",
      "PackageDescription": "50 mL in 1 VIAL (65044-2098-4) ",
      "NDC11Code": "65044-2098-04",
      "ProductNDC": "65044-2098",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Pollens - Trees, Pecan Carya Carya Illinoensis",
      "NonProprietaryName": "Pecan Carya Carya Illinoensis",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19410419",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103888",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "CARYA ILLINOINENSIS POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/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]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19410419",
      "SamplePackage": "N",
      "IndicationAndUsage": "NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.",
      "Description": "Non-standardized allergenic extracts are labeled “No U.S.  Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution.  Product concentrations vary based on the source.  Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents:  casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements.  Acetone and ether may be used as drying and de-fatting agents.  Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas."
    },
    {
      "NDCCode": "36987-2098-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2098-2)",
      "NDC11Code": "36987-2098-02",
      "ProductNDC": "36987-2098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Saccharomyces Cerevisiae",
      "NonProprietaryName": "Saccharomyces Cerevisiae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "SACCHAROMYCES CEREVISIAE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "37662-2098-2",
      "PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-2098-2) ",
      "NDC11Code": "37662-2098-02",
      "ProductNDC": "37662-2098",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sepia",
      "NonProprietaryName": "Sepia",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221214",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "SEPIA OFFICINALIS JUICE",
      "StrengthNumber": "12",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221214",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63083-2098-2",
      "PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-2098-2) ",
      "NDC11Code": "63083-2098-02",
      "ProductNDC": "63083-2098",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anxious Drops",
      "ProprietaryNameSuffix": "2098",
      "NonProprietaryName": "Anxious Drops",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "19840815",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Professional Complementary Health Formulas",
      "SubstanceName": "SODIUM BORATE; SODIUM CHLORIDE; ASTRAGALUS AMERICANUS WHOLE; CAUSTICUM; ELETTARIA ENSAL WHOLE; LEAD; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; GELSEMIUM SEMPERVIRENS ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING",
      "StrengthNumber": "4; 4; 6; 6; 6; 12; 12; 12; 12; 30",
      "StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19850815",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68745-2098-2",
      "PackageDescription": "1 BOTTLE in 1 CARTON (68745-2098-2)  > 20 mL in 1 BOTTLE",
      "NDC11Code": "68745-2098-02",
      "ProductNDC": "68745-2098",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vitalumiere Aqua",
      "ProprietaryNameSuffix": "Ultra-light Skin Perfecting Sunscreen Makeup Broad Spectrum Spf 15, 21 Beige",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181001",
      "EndMarketingDate": "20211215",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CHANEL PARFUMS BEAUTE",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": "60; 56",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20181001",
      "EndMarketingDatePackage": "20211215",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70518-2098-2",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2098-2) ",
      "NDC11Code": "70518-2098-02",
      "ProductNDC": "70518-2098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190522",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203244",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20230924",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
      "Description": "The active ingredient in gabapentin tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin and copovidone, hydroxyl propyl cellulose, magnesium stearate, mannitol, poloxamer, talc, low-substituted hydroxypropyl cellulose and opadry II (white). Opadry II (white) contains polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc."
    },
    {
      "NDCCode": "71335-2098-2",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71335-2098-2) ",
      "NDC11Code": "71335-2098-02",
      "ProductNDC": "71335-2098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078154",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240403",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets USP are indicated for adjunctive therapy for  treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1), 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
      "Description": "Levetiracetam USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake, FD&C Yellow No. 6/sunset yellow FCF Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide."
    },
    {
      "NDCCode": "72934-2098-2",
      "PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-2098-2) ",
      "NDC11Code": "72934-2098-02",
      "ProductNDC": "72934-2098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hyaluronic Acid Sodium Salt 2% / Mometasone Furoate 0.1% / Niacinamide 4%",
      "NonProprietaryName": "Hyaluronic Acid Sodium Salt 2% / Mometasone Furoate 0.1% / Niacinamide 4%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190521",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Sincerus Florida, LLC",
      "SubstanceName": "HYALURONIC ACID; MOMETASONE FUROATE; NIACINAMIDE",
      "StrengthNumber": "2; .1; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190521",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "85816-2098-2",
      "PackageDescription": "500 mL in 1 JAR (85816-2098-2) ",
      "NDC11Code": "85816-2098-02",
      "ProductNDC": "85816-2098",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bm Bm98 Drops",
      "NonProprietaryName": "Acid Sulph, Amyl Nitrosum, Aquilegia, Cimicifuga, Pulsatilla, Sanguinaria, Sabina",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150101",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "BM Private Limited",
      "SubstanceName": "BLACK COHOSH; AMYL NITRITE; AQUILEGIA VULGARIS; PULSATILLA PRATENSIS FLOWERING TOP; JUNIPERUS SABINA LEAFY TWIG; SULFURIC ACID; SANGUINARIA CANADENSIS ROOT",
      "StrengthNumber": "10; 100; 100; 30; 7; 7; 4",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indications: For detail please read the enclosed package (Product information leaflet)."
    },
    {
      "NDCCode": "0031-2098-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0031-2098-01)  / 118 mL in 1 BOTTLE",
      "NDC11Code": "00031-2098-01",
      "ProductNDC": "0031-2098",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Childrens Robitussin Elderberry Cough And Chest Congestion Dm",
      "NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210614",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Haleon US Holdings LLC",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
      "StrengthNumber": "20; 400",
      "StrengthUnit": "mg/20mL; mg/20mL",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210614",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold, 2 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes."
    },
    {
      "NDCCode": "0378-2098-01",
      "PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2098-01) ",
      "NDC11Code": "00378-2098-01",
      "ProductNDC": "0378-2098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nisoldipine",
      "NonProprietaryName": "Nisoldipine",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110128",
      "EndMarketingDate": "20260331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091001",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "NISOLDIPINE",
      "StrengthNumber": "25.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110128",
      "EndMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nisoldipine extended-release tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.",
      "Description": "Nisoldipine is an extended-release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is (±)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate, C20H24N2O6, and has the structural formula:. Nisoldipine is a yellow crystalline powder, practically insoluble in water, but soluble in acetone, ethanol and methanol. It has a molecular weight of 388.4. Nisoldipine extended-release tablets are film-coated monolithic tablets containing a hydrogel which provides for the controlled release of the drug. Nisoldipine extended-release tablets contain either 8.5 mg, 17 mg, 25.5 mg or 34 mg of nisoldipine for once-a-day oral administration. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the following product specific coloring agents are used. The 8.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 17 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 25.5 mg tablets also contain red iron oxide and yellow iron oxide. The 34 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake."
    },
    {
      "NDCCode": "65044-0537-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0537-2) ",
      "NDC11Code": "65044-0537-02",
      "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": "65044-0545-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0545-2) ",
      "NDC11Code": "65044-0545-02",
      "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": "65044-0546-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0546-2) ",
      "NDC11Code": "65044-0546-02",
      "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": "65044-0611-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0611-2) ",
      "NDC11Code": "65044-0611-02",
      "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": "65044-0612-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0612-2) ",
      "NDC11Code": "65044-0612-02",
      "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": "65044-0718-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0718-2) ",
      "NDC11Code": "65044-0718-02",
      "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": "65044-0719-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0719-2) ",
      "NDC11Code": "65044-0719-02",
      "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": "65044-0777-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0777-2) ",
      "NDC11Code": "65044-0777-02",
      "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": "65044-0778-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0778-2) ",
      "NDC11Code": "65044-0778-02",
      "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": "65044-0787-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0787-2) ",
      "NDC11Code": "65044-0787-02",
      "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": "65044-0788-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0788-2) ",
      "NDC11Code": "65044-0788-02",
      "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": "65044-0825-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0825-2) ",
      "NDC11Code": "65044-0825-02",
      "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": "65044-0826-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0826-2) ",
      "NDC11Code": "65044-0826-02",
      "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": "65044-0831-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0831-2) ",
      "NDC11Code": "65044-0831-02",
      "ProductNDC": "65044-0831",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Timothy",
      "NonProprietaryName": "Standardized Grass Pollen, Timothy",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103879",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "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": "65044-0832-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0832-2) ",
      "NDC11Code": "65044-0832-02",
      "ProductNDC": "65044-0832",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Timothy",
      "NonProprietaryName": "Standardized Grass Pollen, Timothy",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103879",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "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": "65044-0841-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0841-2) ",
      "NDC11Code": "65044-0841-02",
      "ProductNDC": "65044-0841",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Grass Mix 4",
      "NonProprietaryName": "Standardized Grass Pollen, Grass Mix 4",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103873",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "2500; 2500; 2500; 2500",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [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],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19980115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "65044-0842-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-0842-2) ",
      "NDC11Code": "65044-0842-02",
      "ProductNDC": "65044-0842",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Grass Pollen, Grass Mix 4",
      "NonProprietaryName": "Standardized Grass Pollen, Grass Mix 4",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19980115",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103873",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "25000; 25000; 25000; 25000",
      "StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "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."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"65044-2098-2","ProprietaryName":"Pollens - Trees, Pecan Carya Carya Illinoensis","NonProprietaryName":"Pecan Carya Carya Illinoensis"},{"NDCCode":"65044-2098-3","ProprietaryName":"Pollens - Trees, Pecan Carya Carya Illinoensis","NonProprietaryName":"Pecan Carya Carya Illinoensis"},{"NDCCode":"65044-2098-4","ProprietaryName":"Pollens - Trees, Pecan Carya Carya Illinoensis","NonProprietaryName":"Pecan Carya Carya Illinoensis"},{"NDCCode":"36987-2098-2","ProprietaryName":"Saccharomyces Cerevisiae","NonProprietaryName":"Saccharomyces Cerevisiae"},{"NDCCode":"37662-2098-2","ProprietaryName":"Sepia","NonProprietaryName":"Sepia"},{"NDCCode":"63083-2098-2","ProprietaryName":"Anxious Drops","NonProprietaryName":"Anxious Drops"},{"NDCCode":"68745-2098-2","ProprietaryName":"Vitalumiere Aqua","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"70518-2098-2","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"71335-2098-2","ProprietaryName":"Levetiracetam","NonProprietaryName":"Levetiracetam"},{"NDCCode":"72934-2098-2","ProprietaryName":"Hyaluronic Acid Sodium Salt 2% / Mometasone Furoate 0.1% / Niacinamide 4%","NonProprietaryName":"Hyaluronic Acid Sodium Salt 2% / Mometasone Furoate 0.1% / Niacinamide 4%"},{"NDCCode":"85816-2098-2","ProprietaryName":"Bm Bm98 Drops","NonProprietaryName":"Acid Sulph, Amyl Nitrosum, Aquilegia, Cimicifuga, Pulsatilla, Sanguinaria, Sabina"},{"NDCCode":"0031-2098-01","ProprietaryName":"Childrens Robitussin Elderberry Cough And Chest Congestion Dm","NonProprietaryName":"Dextromethorphan Hbr, Guaifenesin"},{"NDCCode":"0378-2098-01","ProprietaryName":"Nisoldipine","NonProprietaryName":"Nisoldipine"},{"NDCCode":"65044-0537-2","ProprietaryName":"Standardized Grass Pollen, Bermuda Grass","NonProprietaryName":"Standardized Grass Pollen, Bermuda Grass"},{"NDCCode":"65044-0545-2","ProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June","NonProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June"},{"NDCCode":"65044-0546-2","ProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June","NonProprietaryName":"Standardized Grass Pollen, Bluegrass, Kentucky June"},{"NDCCode":"65044-0611-2","ProprietaryName":"Standardized Grass Pollen, Fescue, Meadow","NonProprietaryName":"Standardized Grass Pollen, Fescue, Meadow"},{"NDCCode":"65044-0612-2","ProprietaryName":"Standardized Grass Pollen, Fescue, Meadow","NonProprietaryName":"Standardized Grass Pollen, Fescue, Meadow"},{"NDCCode":"65044-0718-2","ProprietaryName":"Standardized Grass Pollen, Orchard Grass","NonProprietaryName":"Standardized Grass Pollen, Orchard Grass"},{"NDCCode":"65044-0719-2","ProprietaryName":"Standardized Grass Pollen, Orchard Grass","NonProprietaryName":"Standardized Grass Pollen, Orchard Grass"},{"NDCCode":"65044-0777-2","ProprietaryName":"Standardized Grass Pollen, Redtop","NonProprietaryName":"Standardized Grass Pollen, Redtop"},{"NDCCode":"65044-0778-2","ProprietaryName":"Standardized Grass Pollen, Redtop","NonProprietaryName":"Standardized Grass Pollen, Redtop"},{"NDCCode":"65044-0787-2","ProprietaryName":"Standardized Grass Pollen, Ryegrass","NonProprietaryName":"Standardized Grass Pollen, Ryegrass"},{"NDCCode":"65044-0788-2","ProprietaryName":"Standardized Grass Pollen, Ryegrass","NonProprietaryName":"Standardized Grass Pollen, Ryegrass"},{"NDCCode":"65044-0825-2","ProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass","NonProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass"},{"NDCCode":"65044-0826-2","ProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass","NonProprietaryName":"Standardized Grass Pollen, Sweet Vernal Grass"},{"NDCCode":"65044-0831-2","ProprietaryName":"Standardized Grass Pollen, Timothy","NonProprietaryName":"Standardized Grass Pollen, Timothy"},{"NDCCode":"65044-0832-2","ProprietaryName":"Standardized Grass Pollen, Timothy","NonProprietaryName":"Standardized Grass Pollen, Timothy"},{"NDCCode":"65044-0841-2","ProprietaryName":"Standardized Grass Pollen, Grass Mix 4","NonProprietaryName":"Standardized Grass Pollen, Grass Mix 4"},{"NDCCode":"65044-0842-2","ProprietaryName":"Standardized Grass Pollen, Grass Mix 4","NonProprietaryName":"Standardized Grass Pollen, Grass Mix 4"}]}
                    

<NDCList><NDC><NDCCode>65044-2098-2</NDCCode><ProprietaryName>Pollens - Trees, Pecan Carya Carya Illinoensis</ProprietaryName><NonProprietaryName>Pecan Carya Carya Illinoensis</NonProprietaryName></NDC><NDC><NDCCode>65044-2098-3</NDCCode><ProprietaryName>Pollens - Trees, Pecan Carya Carya Illinoensis</ProprietaryName><NonProprietaryName>Pecan Carya Carya Illinoensis</NonProprietaryName></NDC><NDC><NDCCode>65044-2098-4</NDCCode><ProprietaryName>Pollens - Trees, Pecan Carya Carya Illinoensis</ProprietaryName><NonProprietaryName>Pecan Carya Carya Illinoensis</NonProprietaryName></NDC><NDC><NDCCode>36987-2098-2</NDCCode><ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName><NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName></NDC><NDC><NDCCode>37662-2098-2</NDCCode><ProprietaryName>Sepia</ProprietaryName><NonProprietaryName>Sepia</NonProprietaryName></NDC><NDC><NDCCode>63083-2098-2</NDCCode><ProprietaryName>Anxious Drops</ProprietaryName><NonProprietaryName>Anxious Drops</NonProprietaryName></NDC><NDC><NDCCode>68745-2098-2</NDCCode><ProprietaryName>Vitalumiere Aqua</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>70518-2098-2</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>71335-2098-2</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>72934-2098-2</NDCCode><ProprietaryName>Hyaluronic Acid Sodium Salt 2% / Mometasone Furoate 0.1% / Niacinamide 4%</ProprietaryName><NonProprietaryName>Hyaluronic Acid Sodium Salt 2% / Mometasone Furoate 0.1% / Niacinamide 4%</NonProprietaryName></NDC><NDC><NDCCode>85816-2098-2</NDCCode><ProprietaryName>Bm Bm98 Drops</ProprietaryName><NonProprietaryName>Acid Sulph, Amyl Nitrosum, Aquilegia, Cimicifuga, Pulsatilla, Sanguinaria, Sabina</NonProprietaryName></NDC><NDC><NDCCode>0031-2098-01</NDCCode><ProprietaryName>Childrens Robitussin Elderberry Cough And Chest Congestion Dm</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>0378-2098-01</NDCCode><ProprietaryName>Nisoldipine</ProprietaryName><NonProprietaryName>Nisoldipine</NonProprietaryName></NDC><NDC><NDCCode>65044-0537-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Bermuda Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bermuda Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0545-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</NonProprietaryName></NDC><NDC><NDCCode>65044-0546-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</NonProprietaryName></NDC><NDC><NDCCode>65044-0611-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Fescue, Meadow</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Fescue, Meadow</NonProprietaryName></NDC><NDC><NDCCode>65044-0612-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Fescue, Meadow</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Fescue, Meadow</NonProprietaryName></NDC><NDC><NDCCode>65044-0718-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Orchard Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Orchard Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0719-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Orchard Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Orchard Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0777-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Redtop</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Redtop</NonProprietaryName></NDC><NDC><NDCCode>65044-0778-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Redtop</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Redtop</NonProprietaryName></NDC><NDC><NDCCode>65044-0787-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName></NDC><NDC><NDCCode>65044-0788-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName></NDC><NDC><NDCCode>65044-0825-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0826-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName></NDC><NDC><NDCCode>65044-0831-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Timothy</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Timothy</NonProprietaryName></NDC><NDC><NDCCode>65044-0832-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Timothy</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Timothy</NonProprietaryName></NDC><NDC><NDCCode>65044-0841-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Grass Mix 4</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Grass Mix 4</NonProprietaryName></NDC><NDC><NDCCode>65044-0842-2</NDCCode><ProprietaryName>Standardized Grass Pollen, Grass Mix 4</ProprietaryName><NonProprietaryName>Standardized Grass Pollen, Grass Mix 4</NonProprietaryName></NDC></NDCList>