RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>22840-1654-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-1654-4) </PackageDescription>
    <NDC11Code>22840-1654-04</NDC11Code>
    <ProductNDC>22840-1654</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Cladosporium Herbarum</ProprietaryName>
    <NonProprietaryName>Cladosporium Herbarum</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>CLADOSPORIUM HERBARUM</SubstanceName>
    <StrengthNumber>20000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-1654-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1654-2) </PackageDescription>
    <NDC11Code>22840-1654-02</NDC11Code>
    <ProductNDC>22840-1654</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Cladosporium Herbarum</ProprietaryName>
    <NonProprietaryName>Cladosporium Herbarum</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>CLADOSPORIUM HERBARUM</SubstanceName>
    <StrengthNumber>20000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1654-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1654-4)</PackageDescription>
    <NDC11Code>36987-1654-04</NDC11Code>
    <ProductNDC>36987-1654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Orange Pekoe Tea</ProprietaryName>
    <NonProprietaryName>Orange Pekoe Tea</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>TEA LEAF</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <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.</IndicationAndUsage>
    <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.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-1654-4</NDCCode>
    <PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-1654-4) </PackageDescription>
    <NDC11Code>37662-1654-04</NDC11Code>
    <ProductNDC>37662-1654</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Glonoinum</ProprietaryName>
    <NonProprietaryName>Glonoinum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221003</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>NITROGLYCERIN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>[hp_M]/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221003</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>38779-1654-4</NDCCode>
    <PackageDescription>25 g in 1 JAR (38779-1654-4) </PackageDescription>
    <NDC11Code>38779-1654-04</NDC11Code>
    <ProductNDC>38779-1654</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Thyroid, Porcine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20090522</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Medisca Inc.</LabelerName>
    <SubstanceName>THYROID</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-27</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>22-MAY-09</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>70710-1654-1</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (70710-1654-1)  &gt; 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>70710-1654-01</NDC11Code>
    <ProductNDC>70710-1654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pemetrexed</ProprietaryName>
    <NonProprietaryName>Pemetrexed Disodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220526</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214073</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>PEMETREXED DISODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/4mL</StrengthUnit>
    <Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220526</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pemetrexed for injection, USP is a folate analog metabolic inhibitor indicated: 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. (1.1), 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1), 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1), 5 Limitations of Use : Pemetrexed for injection, USP is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1), 6 initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2).</IndicationAndUsage>
    <Description>Pemetrexed for injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium 2.5 hydrate, has the chemical name N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl-L-glutamic acid, disodium salt, dihydrate and hemihydrate with a molecular formula of C20H19N5Na2O62.5H2O and a molecular weight of 516.41. The structural formula is as follows. Pemetrexed for injection, USP is a sterile white to either light yellow or green-yellow lyophilized powder or cake in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of pemetrexed for injection, USP contains 100 mg pemetrexed (equivalent to 110.28 mg pemetrexed disodium) and 106 mg mannitol USP. Each 500-mg vial of pemetrexed for injection, USP contains 500 mg pemetrexed (equivalent to 551.4 mg pemetrexed disodium) and 500 mg mannitol USP. Each 1000-mg vial of pemetrexed for injection, USP contains 1000 mg pemetrexed (equivalent to 1102.8 mg pemetrexed disodium) and 1000 mg mannitol USP. Hydrochloric acid NF and/or sodium hydroxide NF may have been added to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>51662-1654-1</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, SINGLE-DOSE (51662-1654-1) </PackageDescription>
    <NDC11Code>51662-1654-01</NDC11Code>
    <ProductNDC>51662-1654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Xylocaine Mpf</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
    <StartMarketingDate>20100812</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA006488</ApplicationNumber>
    <LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
    <Description>Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C14H22N2O  HCl) has the following structural formula. Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21. Epinephrine (C9H13NO3) has the following structural formula. Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine in multiple dose vials: Each mL also contains 1 mg methyl­paraben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-1654-1</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, PLASTIC (53002-1654-1) </PackageDescription>
    <NDC11Code>53002-1654-01</NDC11Code>
    <ProductNDC>53002-1654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefdinir</ProprietaryName>
    <NonProprietaryName>Cefdinir</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070508</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065332</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CEFDINIR</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
    <Description>Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-1654-2</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, PLASTIC (53002-1654-2) </PackageDescription>
    <NDC11Code>53002-1654-02</NDC11Code>
    <ProductNDC>53002-1654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefdinir</ProprietaryName>
    <NonProprietaryName>Cefdinir</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070508</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065332</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CEFDINIR</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
    <Description>Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1654-3</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (60219-1654-3)  / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>60219-1654-03</NDC11Code>
    <ProductNDC>60219-1654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brexpiprazole</ProprietaryName>
    <NonProprietaryName>Brexpiprazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230207</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213562</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>BREXPIPRAZOLE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brexpiprazole tablets are indicated for: 1 Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults., 2 Treatment of schizophrenia in adults.</IndicationAndUsage>
    <Description>Brexpiprazole, an atypical antipsychotic, is available as brexpiprazole tablets. Brexpiprazole is 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one. The molecular formula is C25H27N3O2S and its molecular weight is 433.57 g/mol. The chemical structure is. Brexpiprazole is a white to pale yellow color powder. Brexpiprazole tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. Colorants include:. 0.25 mg: ferrosferric oxide, iron oxide red, iron oxide yellow and titanium dioxide;. 0.5 mg:   iron oxide red, iron oxide yellow and titanium dioxide;. 1 mg:      iron oxide red, iron oxide yellow and titanium dioxide;. 2 mg:      ferrosferric oxide, iron oxide yellow and titanium dioxide;. 3 mg:      ferrosferric oxide, iron oxide red and titanium dioxide;. 4 mg:      titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0100-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0100-4) </PackageDescription>
    <NDC11Code>22840-0100-04</NDC11Code>
    <ProductNDC>22840-0100</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Cat Hair Allergenic Extract</ProprietaryName>
    <NonProprietaryName>Felis Catus</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920924</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103397</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>FELIS CATUS DANDER; FELIS CATUS SKIN</SubstanceName>
    <StrengthNumber>5000; 5000</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19920924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Cat Hair Allergenic Extract is indicated for: 1 Skin test diagnosis of patients with a history of allergy to cats., 2 Treatment of cat hair-induced allergic asthma, rhinitis and conjunctivitis. Immunotherapy is indicated when cat allergy is established and the patient cannot avoid exposure to cat allergens.</IndicationAndUsage>
    <Description>GREER Standardized Cat Hair Allergenic Extract is a sterile solution of extracted cat pelt and cat dander. Each vial contains sterile Standardized Cat Hair Allergenic Extract at 10,000 BAU/milliliter or 5,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol volume/volume (preservative). Inactive ingredients include 0.5% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. GREER Standardized Cat Hair Allergenic Extract is labeled in BAU/milliliter. This allergenic extract is not interchangeable with Standardized Cat Pelt Extract or with cat extracts labeled in Allergy Units. The extract is standardized by comparing potency of cat allergen (Fel d 1) units by radial immunodiffusion against a reference standard from the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA). 4,5 An extract with 10.0 to 19.9 Fel d 1 units per milliliter is designated as 10,000 BAU/milliliter by the FDA based on quantitative skin testing. 4,5.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0101-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0101-4) </PackageDescription>
    <NDC11Code>22840-0101-04</NDC11Code>
    <ProductNDC>22840-0101</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Cat Hair Allergenic Extract</ProprietaryName>
    <NonProprietaryName>Felis Catus</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19920924</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103397</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>FELIS CATUS DANDER; FELIS CATUS SKIN</SubstanceName>
    <StrengthNumber>10000; 10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19920924</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Cat Hair Allergenic Extract is indicated for: 1 Skin test diagnosis of patients with a history of allergy to cats., 2 Treatment of cat hair-induced allergic asthma, rhinitis and conjunctivitis. Immunotherapy is indicated when cat allergy is established and the patient cannot avoid exposure to cat allergens.</IndicationAndUsage>
    <Description>GREER Standardized Cat Hair Allergenic Extract is a sterile solution of extracted cat pelt and cat dander. Each vial contains sterile Standardized Cat Hair Allergenic Extract at 10,000 BAU/milliliter or 5,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol volume/volume (preservative). Inactive ingredients include 0.5% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. GREER Standardized Cat Hair Allergenic Extract is labeled in BAU/milliliter. This allergenic extract is not interchangeable with Standardized Cat Pelt Extract or with cat extracts labeled in Allergy Units. The extract is standardized by comparing potency of cat allergen (Fel d 1) units by radial immunodiffusion against a reference standard from the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA). 4,5 An extract with 10.0 to 19.9 Fel d 1 units per milliliter is designated as 10,000 BAU/milliliter by the FDA based on quantitative skin testing. 4,5.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0200-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0200-4) </PackageDescription>
    <NDC11Code>22840-0200-04</NDC11Code>
    <ProductNDC>22840-0200</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Bermuda Grass Pollen</ProprietaryName>
    <NonProprietaryName>Cynodon Dactylon</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101836</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>CYNODON DACTYLON POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0201-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0201-4) </PackageDescription>
    <NDC11Code>22840-0201-04</NDC11Code>
    <ProductNDC>22840-0201</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Kentucky (june) Bluegrass Pollen</ProprietaryName>
    <NonProprietaryName>Poa Pratensis</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101837</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0202-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0202-4) </PackageDescription>
    <NDC11Code>22840-0202-04</NDC11Code>
    <ProductNDC>22840-0202</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Kentucky (june) Bluegrass Pollen</ProprietaryName>
    <NonProprietaryName>Poa Pratensis</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101837</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0203-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0203-4) </PackageDescription>
    <NDC11Code>22840-0203-04</NDC11Code>
    <ProductNDC>22840-0203</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Meadow Fescue Pollen</ProprietaryName>
    <NonProprietaryName>Festuca Elatior</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101838</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>LOLIUM PRATENSE POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0204-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0204-4) </PackageDescription>
    <NDC11Code>22840-0204-04</NDC11Code>
    <ProductNDC>22840-0204</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Meadow Fescue Pollen</ProprietaryName>
    <NonProprietaryName>Festuca Elatior</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101838</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>LOLIUM PRATENSE POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0205-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0205-4) </PackageDescription>
    <NDC11Code>22840-0205-04</NDC11Code>
    <ProductNDC>22840-0205</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Orchard Grass Pollen</ProprietaryName>
    <NonProprietaryName>Dactylis Glomerata</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101839</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>DACTYLIS GLOMERATA POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0206-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0206-4) </PackageDescription>
    <NDC11Code>22840-0206-04</NDC11Code>
    <ProductNDC>22840-0206</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Orchard Grass Pollen</ProprietaryName>
    <NonProprietaryName>Dactylis Glomerata</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101839</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>DACTYLIS GLOMERATA POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0207-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0207-4) </PackageDescription>
    <NDC11Code>22840-0207-04</NDC11Code>
    <ProductNDC>22840-0207</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Redtop Pollen</ProprietaryName>
    <NonProprietaryName>Agrostis Alba</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101840</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0208-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0208-4) </PackageDescription>
    <NDC11Code>22840-0208-04</NDC11Code>
    <ProductNDC>22840-0208</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Redtop Pollen</ProprietaryName>
    <NonProprietaryName>Agrostis Alba</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101840</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <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]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0209-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0209-4) </PackageDescription>
    <NDC11Code>22840-0209-04</NDC11Code>
    <ProductNDC>22840-0209</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Perennial Ryegrass Pollen</ProprietaryName>
    <NonProprietaryName>Lolium Perenne</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101841</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>LOLIUM PERENNE POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0210-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0210-4) </PackageDescription>
    <NDC11Code>22840-0210-04</NDC11Code>
    <ProductNDC>22840-0210</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Perennial Ryegrass Pollen</ProprietaryName>
    <NonProprietaryName>Lolium Perenne</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101841</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>LOLIUM PERENNE POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0211-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0211-4) </PackageDescription>
    <NDC11Code>22840-0211-04</NDC11Code>
    <ProductNDC>22840-0211</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Sweet Vernal Grass Pollen</ProprietaryName>
    <NonProprietaryName>Anthoxanthum Odoratum</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101842</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0212-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0212-4) </PackageDescription>
    <NDC11Code>22840-0212-04</NDC11Code>
    <ProductNDC>22840-0212</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Sweet Vernal Grass Pollen</ProprietaryName>
    <NonProprietaryName>Anthoxanthum Odoratum</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101842</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0213-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0213-4) </PackageDescription>
    <NDC11Code>22840-0213-04</NDC11Code>
    <ProductNDC>22840-0213</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Timothy Pollen</ProprietaryName>
    <NonProprietaryName>Phleum Pratense</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101843</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>PHLEUM PRATENSE POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0214-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0214-4) </PackageDescription>
    <NDC11Code>22840-0214-04</NDC11Code>
    <ProductNDC>22840-0214</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Timothy Pollen</ProprietaryName>
    <NonProprietaryName>Phleum Pratense</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101843</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>PHLEUM PRATENSE POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0215-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0215-4) </PackageDescription>
    <NDC11Code>22840-0215-04</NDC11Code>
    <ProductNDC>22840-0215</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Timothy-orchard Standardized Grass Pollen Mix</ProprietaryName>
    <NonProprietaryName>Phleum Pratense And Dactylis Glomerata</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101843</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
    <StrengthNumber>50000; 50000</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0216-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0216-4) </PackageDescription>
    <NDC11Code>22840-0216-04</NDC11Code>
    <ProductNDC>22840-0216</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>K-o-t Standardized Grass Pollen Mix</ProprietaryName>
    <NonProprietaryName>Poa Pratensis, Dactylis Glomerata And Phleum Pratense</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101837</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
    <StrengthNumber>3333.333; 3333.333; 3333.333</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-0217-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0217-4) </PackageDescription>
    <NDC11Code>22840-0217-04</NDC11Code>
    <ProductNDC>22840-0217</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>K-o-t Standardized Grass Pollen Mix</ProprietaryName>
    <NonProprietaryName>Poa Pratensis, Dactylis Glomerata And Phleum Pratense</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101837</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
    <StrengthNumber>33333.333; 33333.333; 33333.333</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
</NDCList>