RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "0268-1531-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-1531-50) ",
      "NDC11Code": "00268-1531-50",
      "ProductNDC": "0268-1531",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Ambrosia Artemisiifolia Pollen",
      "NonProprietaryName": "Ragweed Short",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "AMBROSIA ARTEMISIIFOLIA POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19650101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
      "Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
    },
    {
      "NDCCode": "0268-1531-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-1531-10) ",
      "NDC11Code": "00268-1531-10",
      "ProductNDC": "0268-1531",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Ambrosia Artemisiifolia Pollen",
      "NonProprietaryName": "Ragweed Short",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "AMBROSIA ARTEMISIIFOLIA POLLEN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19650101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
      "Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
    },
    {
      "NDCCode": "36987-1531-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1531-4)",
      "NDC11Code": "36987-1531-04",
      "ProductNDC": "36987-1531",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Brazil Nut",
      "NonProprietaryName": "Brazil Nut",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BRAZIL NUT",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "51662-1531-3",
      "PackageDescription": "50 POUCH in 1 CARTON (51662-1531-3)  / 1 CARTON in 1 POUCH (51662-1531-2)  / 1 SYRINGE, GLASS in 1 CARTON / 10 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "51662-1531-03",
      "ProductNDC": "51662-1531",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epinephrine",
      "NonProprietaryName": "Epinephrine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210425",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209359",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "EPINEPHRINE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210425",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Hypotension associated with Septic Shock. Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.",
      "Description": "Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is supplied as a sterile aqueous solution with a pH range of 2.3–3.5, that is clear, colorless, and nonpyrogenic. Each milliliter contains 0.1 mg epinephrine, 8.16 mg sodium chloride, 0.46 mg sodium metabisulfite, and 2.13 mg citric acid, anhydrous and 0.41 mg sodium citrate, dihydrate added as buffers. Additional citric acid and/or sodium citrate may be added for pH adjustment. The solution contains no preservatives. This sterile solution is to be administered after dilution by the intravenous route. Epinephrine is a sympathomimetic catecholamine (adrenergic agent) designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, crystalline powder. It has the following structural formula. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
    },
    {
      "NDCCode": "60219-1531-6",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (60219-1531-6)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "60219-1531-06",
      "ProductNDC": "60219-1531",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201108",
      "LabelerName": "Amneal Pharmaceuticals NY LLC",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table II: Percentage of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.¶. Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Gust F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. * Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. † Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ‡ Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience and accidental pregnancy during the first year if they do not stop use for any other reason. § The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. ¶ However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. # The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. Þ Foams, creams, gels, vaginal suppositories, and vaginal film. ß Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. à With spermicidal cream or jelly. è Without spermicides. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 women-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
      "Description": "Each active, white tablet (21) contains 0.1 mg of levonorgestrel, USP, d (-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, USP, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and Aqua Polish White 014.17 MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil, hydroxypropylmethylcellulose, talc, and titanium dioxide. Each inactive, yellow tablet (7) contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and Aqua Polish Yellow 024.15 MS which contains hydroxypropylcellulose, hydrogenated cottonseed oil, hydroxypropylmethylcellulose, ferric oxide red, ferric oxide yellow, talc, and titanium dioxide."
    },
    {
      "NDCCode": "70710-1531-1",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1531-1)  / 25 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "70710-1531-01",
      "ProductNDC": "70710-1531",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxorubicin Hydrochloride",
      "NonProprietaryName": "Doxorubicin Hydrochloride",
      "DosageFormName": "INJECTABLE, LIPOSOMAL",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200914",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212299",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxorubicin hydrochloride liposome injection is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer: After failure of platinum-based chemotherapy (1.1), 2 AIDS-related Kaposi's Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2), 3 Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3).",
      "Description": "Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11∙HCl and the molecular weight is 579.99. The structural formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin). The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2,000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.50 mg as a buffer; hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0 to 7.0); and sucrose, 95.50 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes. MPEG-DSPE has the following structural formula. HSPC has the following structural formula. Representation of a pegylated liposome."
    },
    {
      "NDCCode": "0168-0268-50",
      "PackageDescription": "50 g in 1 TUBE (0168-0268-50) ",
      "NDC11Code": "00168-0268-50",
      "ProductNDC": "0168-0268",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Betamethasone Dipropionate",
      "NonProprietaryName": "Betamethasone Dipropionate",
      "DosageFormName": "OINTMENT, AUGMENTED",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19990622",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075373",
      "LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
      "SubstanceName": "BETAMETHASONE DIPROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19990622",
      "SamplePackage": "N",
      "IndicationAndUsage": "Betamethasone dipropionate ointment (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.",
      "Description": "Betamethasone dipropionate ointment USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6 and the following structural formula. Betamethasone dipropionate is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white ointment base of propylene glycol, propylene glycol monostearate, beeswax and white petrolatum."
    },
    {
      "NDCCode": "0268-0002-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0002-50)",
      "NDC11Code": "00268-0002-50",
      "ProductNDC": "0268-0002",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "House Dust",
      "NonProprietaryName": "House Dust",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "HOUSE DUST",
      "StrengthNumber": "10000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0268-0004-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0004-50)",
      "NDC11Code": "00268-0004-50",
      "ProductNDC": "0268-0004",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "House Dust",
      "NonProprietaryName": "House Dust",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "HOUSE DUST",
      "StrengthNumber": "20000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0268-0005-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0005-50)",
      "NDC11Code": "00268-0005-50",
      "ProductNDC": "0268-0005",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "House Dust",
      "NonProprietaryName": "House Dust",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "HOUSE DUST",
      "StrengthNumber": "40000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0268-0009-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0009-50)",
      "NDC11Code": "00268-0009-50",
      "ProductNDC": "0268-0009",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "House Dust",
      "NonProprietaryName": "House Dust",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "HOUSE DUST",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0268-0011-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0011-50)",
      "NDC11Code": "00268-0011-50",
      "ProductNDC": "0268-0011",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "House Dust",
      "NonProprietaryName": "House Dust",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "HOUSE DUST",
      "StrengthNumber": "20000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0268-0012-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0012-50)",
      "NDC11Code": "00268-0012-50",
      "ProductNDC": "0268-0012",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "House Dust",
      "NonProprietaryName": "House Dust",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "HOUSE DUST",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0268-0013-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0013-50)",
      "NDC11Code": "00268-0013-50",
      "ProductNDC": "0268-0013",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "House Dust",
      "NonProprietaryName": "House Dust",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19650101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103753",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "HOUSE DUST",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0268-0275-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0275-50) ",
      "NDC11Code": "00268-0275-50",
      "ProductNDC": "0268-0275",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Mite D. Farinae",
      "NonProprietaryName": "Standardized Mite D. Farinae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19910708",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103060",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19910708",
      "SamplePackage": "N",
      "IndicationAndUsage": "This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.",
      "Description": "Allergenic Extract Standardized Mite in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride for isotonicity and sodium bicarbonates, as a buffer. The mites (D. farinae and/or D. pteronyssinus). used as source material for this extract, were cultured by Biopol Laboratories on a medium consisting of yeast and pork. The whole-body mites were separated from the culture medium and the harvested mites contained less than 1% culture medium material. Several manufacturers submitted to FDA, intradermal skin test data on Biopol Laboratory’s mite medium extract using patients who were puncture test positive (sum of erythema equal to or greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (sum of erythema equal to or greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive also skin tested by the puncture method with an extract of yeast (Saccharomyces sp) and were positive. In ten mite sensitive patients, ALK-Abelló, Inc. observed no puncture or intradermal reactions to media from the same source at a carryover concentration equivalent to 1% of the mite extract. For ease in use, and for lot to lot consistency, potency value is expressed in allergy units per milliliter. This ELISA standardized mite extract was compared to a mite reference preparation supplied by FDA which was labeled 10,000 AU/mL based on skin testing.1 The relative potency of this mite extract was determined by ELISA inhibition in comparison to the FDA Mite reference and is labeled in AU's (Allergy Units/mL).2 Dilutions made from this product can be administered intradermally for testing, or subcutaneously for immunotherapy."
    },
    {
      "NDCCode": "0268-0276-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0276-50) ",
      "NDC11Code": "00268-0276-50",
      "ProductNDC": "0268-0276",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Mite D. Farinae",
      "NonProprietaryName": "Standardized Mite D. Farinae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19910708",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103060",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "5000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "19910708",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0268-0277-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0277-50) ",
      "NDC11Code": "00268-0277-50",
      "ProductNDC": "0268-0277",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Mite D. Pteronyssinus",
      "NonProprietaryName": "Standardized Mite D. Pteronyssinus",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19900814",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103752",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19900814",
      "SamplePackage": "N",
      "IndicationAndUsage": "This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.",
      "Description": "Allergenic Extract Standardized Mite in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride for isotonicity and sodium bicarbonates, as a buffer. The mites (D. farinae and/or D. pteronyssinus). used as source material for this extract, were cultured by Biopol Laboratories on a medium consisting of yeast and pork. The whole-body mites were separated from the culture medium and the harvested mites contained less than 1% culture medium material. Several manufacturers submitted to FDA, intradermal skin test data on Biopol Laboratory’s mite medium extract using patients who were puncture test positive (sum of erythema equal to or greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (sum of erythema equal to or greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive also skin tested by the puncture method with an extract of yeast (Saccharomyces sp) and were positive. In ten mite sensitive patients, ALK-Abelló, Inc. observed no puncture or intradermal reactions to media from the same source at a carryover concentration equivalent to 1% of the mite extract. For ease in use, and for lot to lot consistency, potency value is expressed in allergy units per milliliter. This ELISA standardized mite extract was compared to a mite reference preparation supplied by FDA which was labeled 10,000 AU/mL based on skin testing.1 The relative potency of this mite extract was determined by ELISA inhibition in comparison to the FDA Mite reference and is labeled in AU's (Allergy Units/mL).2 Dilutions made from this product can be administered intradermally for testing, or subcutaneously for immunotherapy."
    },
    {
      "NDCCode": "0268-0278-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0278-50) ",
      "NDC11Code": "00268-0278-50",
      "ProductNDC": "0268-0278",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Mite D. Pteronyssinus",
      "NonProprietaryName": "Standardized Mite D. Pteronyssinus",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19900814",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103752",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
      "StrengthNumber": "5000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "19900814",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0268-0279-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0279-50) ",
      "NDC11Code": "00268-0279-50",
      "ProductNDC": "0268-0279",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Timothy, Standardized",
      "NonProprietaryName": "Timothy, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103058",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    },
    {
      "NDCCode": "0268-0280-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0280-50) ",
      "NDC11Code": "00268-0280-50",
      "ProductNDC": "0268-0280",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Timothy, Standardized",
      "NonProprietaryName": "Timothy, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103058",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "PHLEUM PRATENSE POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0268-0281-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0281-50) ",
      "NDC11Code": "00268-0281-50",
      "ProductNDC": "0268-0281",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Orchard Grass, Standardized",
      "NonProprietaryName": "Orchard Grass, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103054",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "DACTYLIS GLOMERATA POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    },
    {
      "NDCCode": "0268-0282-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0282-50) ",
      "NDC11Code": "00268-0282-50",
      "ProductNDC": "0268-0282",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Orchard Grass, Standardized",
      "NonProprietaryName": "Orchard Grass, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103054",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "DACTYLIS GLOMERATA POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0268-0283-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0283-50) ",
      "NDC11Code": "00268-0283-50",
      "ProductNDC": "0268-0283",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Kentucky Bluegrass (june) Standardized",
      "NonProprietaryName": "Kentucky Bluegrass June, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103052",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    },
    {
      "NDCCode": "0268-0284-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0284-50) ",
      "NDC11Code": "00268-0284-50",
      "ProductNDC": "0268-0284",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Kentucky Bluegrass (june) Standardized",
      "NonProprietaryName": "Kentucky Bluegrass June, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103052",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0268-0285-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0285-50) ",
      "NDC11Code": "00268-0285-50",
      "ProductNDC": "0268-0285",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Redtop Grass, Standardized",
      "NonProprietaryName": "Redtop Grass, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103055",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    },
    {
      "NDCCode": "0268-0286-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0286-50) ",
      "NDC11Code": "00268-0286-50",
      "ProductNDC": "0268-0286",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Redtop Grass, Standardized",
      "NonProprietaryName": "Redtop Grass, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103055",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "AGROSTIS GIGANTEA POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0268-0287-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0287-50) ",
      "NDC11Code": "00268-0287-50",
      "ProductNDC": "0268-0287",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Sweet Vernal Grass, Standardized",
      "NonProprietaryName": "Sweet Vernal Grass, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103057",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    },
    {
      "NDCCode": "0268-0289-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0289-50) ",
      "NDC11Code": "00268-0289-50",
      "ProductNDC": "0268-0289",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Rye Grass, Perennial Standardized",
      "NonProprietaryName": "Rye Grass, Perennial Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103056",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "LOLIUM PERENNE POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    },
    {
      "NDCCode": "0268-0290-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0290-50) ",
      "NDC11Code": "00268-0290-50",
      "ProductNDC": "0268-0290",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Rye Grass, Perennial Standardized",
      "NonProprietaryName": "Rye Grass, Perennial Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103056",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "LOLIUM PERENNE POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0268-0291-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0291-50) ",
      "NDC11Code": "00268-0291-50",
      "ProductNDC": "0268-0291",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Meadow Fescue Grass, Standardized",
      "NonProprietaryName": "Meadow Fescue Grass, Standardized",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19971218",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103053",
      "LabelerName": "ALK-Abello, Inc.",
      "SubstanceName": "FESTUCA PRATENSIS POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-05-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19971218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
      "Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"0268-1531-50","ProprietaryName":"Ambrosia Artemisiifolia Pollen","NonProprietaryName":"Ragweed Short"},{"NDCCode":"0268-1531-10","ProprietaryName":"Ambrosia Artemisiifolia Pollen","NonProprietaryName":"Ragweed Short"},{"NDCCode":"36987-1531-4","ProprietaryName":"Brazil Nut","NonProprietaryName":"Brazil Nut"},{"NDCCode":"51662-1531-3","ProprietaryName":"Epinephrine","NonProprietaryName":"Epinephrine"},{"NDCCode":"60219-1531-6","ProprietaryName":"Levonorgestrel And Ethinyl Estradiol","NonProprietaryName":"Levonorgestrel And Ethinyl Estradiol"},{"NDCCode":"70710-1531-1","ProprietaryName":"Doxorubicin Hydrochloride","NonProprietaryName":"Doxorubicin Hydrochloride"},{"NDCCode":"0168-0268-50","ProprietaryName":"Betamethasone Dipropionate","NonProprietaryName":"Betamethasone Dipropionate"},{"NDCCode":"0268-0002-50","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0268-0004-50","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0268-0005-50","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0268-0009-50","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0268-0011-50","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0268-0012-50","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0268-0013-50","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0268-0275-50","ProprietaryName":"Standardized Mite D. Farinae","NonProprietaryName":"Standardized Mite D. Farinae"},{"NDCCode":"0268-0276-50","ProprietaryName":"Standardized Mite D. Farinae","NonProprietaryName":"Standardized Mite D. Farinae"},{"NDCCode":"0268-0277-50","ProprietaryName":"Standardized Mite D. Pteronyssinus","NonProprietaryName":"Standardized Mite D. Pteronyssinus"},{"NDCCode":"0268-0278-50","ProprietaryName":"Standardized Mite D. Pteronyssinus","NonProprietaryName":"Standardized Mite D. Pteronyssinus"},{"NDCCode":"0268-0279-50","ProprietaryName":"Timothy, Standardized","NonProprietaryName":"Timothy, Standardized"},{"NDCCode":"0268-0280-50","ProprietaryName":"Timothy, Standardized","NonProprietaryName":"Timothy, Standardized"},{"NDCCode":"0268-0281-50","ProprietaryName":"Orchard Grass, Standardized","NonProprietaryName":"Orchard Grass, Standardized"},{"NDCCode":"0268-0282-50","ProprietaryName":"Orchard Grass, Standardized","NonProprietaryName":"Orchard Grass, Standardized"},{"NDCCode":"0268-0283-50","ProprietaryName":"Kentucky Bluegrass (june) Standardized","NonProprietaryName":"Kentucky Bluegrass June, Standardized"},{"NDCCode":"0268-0284-50","ProprietaryName":"Kentucky Bluegrass (june) Standardized","NonProprietaryName":"Kentucky Bluegrass June, Standardized"},{"NDCCode":"0268-0285-50","ProprietaryName":"Redtop Grass, Standardized","NonProprietaryName":"Redtop Grass, Standardized"},{"NDCCode":"0268-0286-50","ProprietaryName":"Redtop Grass, Standardized","NonProprietaryName":"Redtop Grass, Standardized"},{"NDCCode":"0268-0287-50","ProprietaryName":"Sweet Vernal Grass, Standardized","NonProprietaryName":"Sweet Vernal Grass, Standardized"},{"NDCCode":"0268-0289-50","ProprietaryName":"Rye Grass, Perennial Standardized","NonProprietaryName":"Rye Grass, Perennial Standardized"},{"NDCCode":"0268-0290-50","ProprietaryName":"Rye Grass, Perennial Standardized","NonProprietaryName":"Rye Grass, Perennial Standardized"},{"NDCCode":"0268-0291-50","ProprietaryName":"Meadow Fescue Grass, Standardized","NonProprietaryName":"Meadow Fescue Grass, Standardized"}]}
                    

<NDCList><NDC><NDCCode>0268-1531-50</NDCCode><ProprietaryName>Ambrosia Artemisiifolia Pollen</ProprietaryName><NonProprietaryName>Ragweed Short</NonProprietaryName></NDC><NDC><NDCCode>0268-1531-10</NDCCode><ProprietaryName>Ambrosia Artemisiifolia Pollen</ProprietaryName><NonProprietaryName>Ragweed Short</NonProprietaryName></NDC><NDC><NDCCode>36987-1531-4</NDCCode><ProprietaryName>Brazil Nut</ProprietaryName><NonProprietaryName>Brazil Nut</NonProprietaryName></NDC><NDC><NDCCode>51662-1531-3</NDCCode><ProprietaryName>Epinephrine</ProprietaryName><NonProprietaryName>Epinephrine</NonProprietaryName></NDC><NDC><NDCCode>60219-1531-6</NDCCode><ProprietaryName>Levonorgestrel And Ethinyl Estradiol</ProprietaryName><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>70710-1531-1</NDCCode><ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName><NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0168-0268-50</NDCCode><ProprietaryName>Betamethasone Dipropionate</ProprietaryName><NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0268-0002-50</NDCCode><ProprietaryName>House Dust</ProprietaryName><NonProprietaryName>House Dust</NonProprietaryName></NDC><NDC><NDCCode>0268-0004-50</NDCCode><ProprietaryName>House Dust</ProprietaryName><NonProprietaryName>House Dust</NonProprietaryName></NDC><NDC><NDCCode>0268-0005-50</NDCCode><ProprietaryName>House Dust</ProprietaryName><NonProprietaryName>House Dust</NonProprietaryName></NDC><NDC><NDCCode>0268-0009-50</NDCCode><ProprietaryName>House Dust</ProprietaryName><NonProprietaryName>House Dust</NonProprietaryName></NDC><NDC><NDCCode>0268-0011-50</NDCCode><ProprietaryName>House Dust</ProprietaryName><NonProprietaryName>House Dust</NonProprietaryName></NDC><NDC><NDCCode>0268-0012-50</NDCCode><ProprietaryName>House Dust</ProprietaryName><NonProprietaryName>House Dust</NonProprietaryName></NDC><NDC><NDCCode>0268-0013-50</NDCCode><ProprietaryName>House Dust</ProprietaryName><NonProprietaryName>House Dust</NonProprietaryName></NDC><NDC><NDCCode>0268-0275-50</NDCCode><ProprietaryName>Standardized Mite D. Farinae</ProprietaryName><NonProprietaryName>Standardized Mite D. Farinae</NonProprietaryName></NDC><NDC><NDCCode>0268-0276-50</NDCCode><ProprietaryName>Standardized Mite D. Farinae</ProprietaryName><NonProprietaryName>Standardized Mite D. Farinae</NonProprietaryName></NDC><NDC><NDCCode>0268-0277-50</NDCCode><ProprietaryName>Standardized Mite D. Pteronyssinus</ProprietaryName><NonProprietaryName>Standardized Mite D. Pteronyssinus</NonProprietaryName></NDC><NDC><NDCCode>0268-0278-50</NDCCode><ProprietaryName>Standardized Mite D. Pteronyssinus</ProprietaryName><NonProprietaryName>Standardized Mite D. Pteronyssinus</NonProprietaryName></NDC><NDC><NDCCode>0268-0279-50</NDCCode><ProprietaryName>Timothy, Standardized</ProprietaryName><NonProprietaryName>Timothy, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0280-50</NDCCode><ProprietaryName>Timothy, Standardized</ProprietaryName><NonProprietaryName>Timothy, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0281-50</NDCCode><ProprietaryName>Orchard Grass, Standardized</ProprietaryName><NonProprietaryName>Orchard Grass, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0282-50</NDCCode><ProprietaryName>Orchard Grass, Standardized</ProprietaryName><NonProprietaryName>Orchard Grass, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0283-50</NDCCode><ProprietaryName>Kentucky Bluegrass (june) Standardized</ProprietaryName><NonProprietaryName>Kentucky Bluegrass June, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0284-50</NDCCode><ProprietaryName>Kentucky Bluegrass (june) Standardized</ProprietaryName><NonProprietaryName>Kentucky Bluegrass June, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0285-50</NDCCode><ProprietaryName>Redtop Grass, Standardized</ProprietaryName><NonProprietaryName>Redtop Grass, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0286-50</NDCCode><ProprietaryName>Redtop Grass, Standardized</ProprietaryName><NonProprietaryName>Redtop Grass, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0287-50</NDCCode><ProprietaryName>Sweet Vernal Grass, Standardized</ProprietaryName><NonProprietaryName>Sweet Vernal Grass, Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0289-50</NDCCode><ProprietaryName>Rye Grass, Perennial Standardized</ProprietaryName><NonProprietaryName>Rye Grass, Perennial Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0290-50</NDCCode><ProprietaryName>Rye Grass, Perennial Standardized</ProprietaryName><NonProprietaryName>Rye Grass, Perennial Standardized</NonProprietaryName></NDC><NDC><NDCCode>0268-0291-50</NDCCode><ProprietaryName>Meadow Fescue Grass, Standardized</ProprietaryName><NonProprietaryName>Meadow Fescue Grass, Standardized</NonProprietaryName></NDC></NDCList>