RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "54575-398-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-398-02)",
      "NDC11Code": "54575-0398-02",
      "ProductNDC": "54575-398",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Grape",
      "NonProprietaryName": "Concord Grape",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "CONCORD GRAPE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Fruit Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-398-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-398-10)",
      "NDC11Code": "54575-0398-10",
      "ProductNDC": "54575-398",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Grape",
      "NonProprietaryName": "Concord Grape",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "CONCORD GRAPE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Fruit Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-398-30",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (54575-398-30)",
      "NDC11Code": "54575-0398-30",
      "ProductNDC": "54575-398",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Grape",
      "NonProprietaryName": "Concord Grape",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "CONCORD GRAPE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Fruit Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-398-50",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (54575-398-50)",
      "NDC11Code": "54575-0398-50",
      "ProductNDC": "54575-398",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Grape",
      "NonProprietaryName": "Concord Grape",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "CONCORD GRAPE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Fruit Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "11673-398-02",
      "PackageDescription": "1 TUBE in 1 CARTON (11673-398-02)  / 28.4 g in 1 TUBE",
      "NDC11Code": "11673-0398-02",
      "ProductNDC": "11673-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hydrocortisone",
      "ProprietaryNameSuffix": "Intensive Healing Formula",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201019",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "TARGET Corporation",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201019",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczemapsoriasispoison ivy, oak, sumacinsect bitesdetergentsjewelrycosmeticssoapsseborrheic dermatitis. temporarily relieves external anal and genital itching. other uses of this product should only be under the advice and supervision of a doctor."
    },
    {
      "NDCCode": "49349-398-02",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (49349-398-02)",
      "NDC11Code": "49349-0398-02",
      "ProductNDC": "49349-398",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110719",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078428",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "51346-398-02",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51346-398-02)  > 55 mL in 1 BOTTLE, PLASTIC (51346-398-01) ",
      "NDC11Code": "51346-0398-02",
      "ProductNDC": "51346-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Snail Solu Tion",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "NATURE REPUBLIC CO., LTD.",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": ".99",
      "StrengthUnit": "g/55mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20161101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "61649-398-02",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (61649-398-02) ",
      "NDC11Code": "61649-0398-02",
      "ProductNDC": "61649-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bio Spectra",
      "ProprietaryNameSuffix": "Attitude",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201115",
      "EndMarketingDate": "20240331",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "BIO SPECTRA",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "72",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20201115",
      "EndMarketingDatePackage": "20240331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "63545-398-02",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (63545-398-02) ",
      "NDC11Code": "63545-0398-02",
      "ProductNDC": "63545-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Baryta Muriatica",
      "NonProprietaryName": "Baryta Muriatica",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220406",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC",
      "SubstanceName": "BARIUM CHLORIDE DIHYDRATE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220406",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68703-398-02",
      "PackageDescription": "59 mL in 1 BOTTLE, GLASS (68703-398-02) ",
      "NDC11Code": "68703-0398-02",
      "ProductNDC": "68703-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nativeremedies Tic Tamer",
      "NonProprietaryName": "Chamomilla, Cina, Hyoscyamus, Zinc Met",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230403",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Silver Star Brands",
      "SubstanceName": "MATRICARIA RECUTITA; ARTEMISIA CINA FLOWER; ZINC; HYOSCYAMUS NIGER",
      "StrengthNumber": "12; 30; 30; 30",
      "StrengthUnit": "[hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL",
      "Status": "Active",
      "LastUpdate": "2025-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230403",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses*: Homeopathic remedy to control involuntary tics and jerking movements. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
    },
    {
      "NDCCode": "69168-398-02",
      "PackageDescription": "150 TABLET, COATED in 1 BOTTLE (69168-398-02) ",
      "NDC11Code": "69168-0398-02",
      "ProductNDC": "69168-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bisacodyl 5mg",
      "NonProprietaryName": "Bisacodyl 5mg",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141223",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "Allegiant Health",
      "SubstanceName": "BISACODYL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2025-03-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240116",
      "SamplePackage": "N",
      "IndicationAndUsage": "for relief of occasional constipation (irregularity). this product generally produces bowel movement in 6 to 12 hours."
    },
    {
      "NDCCode": "72603-398-02",
      "PackageDescription": "90 PACKET in 1 CARTON (72603-398-02)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (72603-398-01) ",
      "NDC11Code": "72603-0398-02",
      "ProductNDC": "72603-398",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sevelamer Carbonate",
      "NonProprietaryName": "Sevelamer Carbonate",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207291",
      "LabelerName": "NorthStar RxLLC",
      "SubstanceName": "SEVELAMER CARBONATE",
      "StrengthNumber": ".8",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
      "Description": "The active ingredient in sevelamer carbonate for oral suspension is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network. Sevelamer Carbonate Powder: Each packet of sevelamer carbonate for oral suspension contains 0.8 g of sevelamer carbonate on an anhydrous basis. The inactive ingredients are mannitol, ferric oxide yellow, povidone k-30, xanthan gum, sodium chloride, sucralose, orange flavor permaseal phs-133147, vanilla flavor 78506-32 and lemon juice flavor phs-221397."
    },
    {
      "NDCCode": "84525-398-02",
      "PackageDescription": "15 g in 1 BOX (84525-398-02) ",
      "NDC11Code": "84525-0398-02",
      "ProductNDC": "84525-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Trstay Jasminum Esseatial Cream",
      "NonProprietaryName": "Trstay Jasminum Esseatial Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250110",
      "EndMarketingDate": "20310110",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Yiwu Zhixin Trade Co Ltd",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250110",
      "EndMarketingDatePackage": "20310110",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "84756-398-02",
      "PackageDescription": "15 g in 1 BOX (84756-398-02) ",
      "NDC11Code": "84756-0398-02",
      "ProductNDC": "84756-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-aging Cream",
      "NonProprietaryName": "Anti-aging Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241122",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Luoxin E �Commerce Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241122",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "84827-398-02",
      "PackageDescription": "15 mL in 1 BOX (84827-398-02) ",
      "NDC11Code": "84827-0398-02",
      "ProductNDC": "84827-398",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Moustache Beard Oil",
      "NonProprietaryName": "Moustache Beard Oil",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241104",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "54575-081-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-081-02)",
      "NDC11Code": "54575-0081-02",
      "ProductNDC": "54575-081",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bahia Grass Pollen",
      "NonProprietaryName": "Paspalum Notatum Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "PASPALUM NOTATUM POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-082-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-082-02)",
      "NDC11Code": "54575-0082-02",
      "ProductNDC": "54575-082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cultivated Barley Pollen",
      "NonProprietaryName": "Hordeum Vulgare Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "HORDEUM VULGARE POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-083-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-083-02)",
      "NDC11Code": "54575-0083-02",
      "ProductNDC": "54575-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Creeping Bent Grass Pollen",
      "NonProprietaryName": "Agrostis Stolonifera Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "AGROSTIS STOLONIFERA POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-084-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-084-02)",
      "NDC11Code": "54575-0084-02",
      "ProductNDC": "54575-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Bermuda Grass Pollen",
      "NonProprietaryName": "Cynodon Dactylon Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19970529",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101379",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "CYNODON DACTYLON POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract.       Grass pollen immunotherapy is intended for patients whose grass allergic symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).",
      "Description": "Standardized grass pollen extracts labeled in BAU/ml are not interchangeable with grass pollen extracts labeled in AU/ml or with non-standardized grass pollen extracts. The recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml.       The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml."
    },
    {
      "NDCCode": "54575-085-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-085-02)",
      "NDC11Code": "54575-0085-02",
      "ProductNDC": "54575-085",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Annual Bluegrass Pollen",
      "NonProprietaryName": "Poa Annua Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "POA ANNUA POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-087-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-087-02)",
      "NDC11Code": "54575-0087-02",
      "ProductNDC": "54575-087",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Kentucky Bluegrass Pollen",
      "NonProprietaryName": "Poa Pratensis Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19970529",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101380",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "POA PRATENSIS POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract.       Grass pollen immunotherapy is intended for patients whose grass allergic symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).",
      "Description": "Standardized grass pollen extracts labeled in BAU/ml are not interchangeable with grass pollen extracts labeled in AU/ml or with non-standardized grass pollen extracts. The recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml.       The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml."
    },
    {
      "NDCCode": "54575-088-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-088-02)",
      "NDC11Code": "54575-0088-02",
      "ProductNDC": "54575-088",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hungarian Smooth Brome Pollen",
      "NonProprietaryName": "Bromus Inermis Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "BROMUS INERMIS POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-089-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-089-02)",
      "NDC11Code": "54575-0089-02",
      "ProductNDC": "54575-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Canary Grass Pollen",
      "NonProprietaryName": "Phalaris Minor Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "PHALARIS MINOR POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-090-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-090-02)",
      "NDC11Code": "54575-0090-02",
      "ProductNDC": "54575-090",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Southern Cheat Chess Pollen",
      "NonProprietaryName": "Bromus Secalinus Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "BROMUS SECALINUS POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-091-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-091-02)",
      "NDC11Code": "54575-0091-02",
      "ProductNDC": "54575-091",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cultivated Corn Pollen",
      "NonProprietaryName": "Zea Mays Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "ZEA MAYS POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Cell-mediated Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-092-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-092-02)",
      "NDC11Code": "54575-0092-02",
      "ProductNDC": "54575-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Meadow Fescue Grass Pollen",
      "NonProprietaryName": "Festuca Elatior Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19970529",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101381",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "FESTUCA PRATENSIS POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract.       Grass pollen immunotherapy is intended for patients whose grass allergic symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5).",
      "Description": "Standardized grass pollen extracts labeled in BAU/ml are not interchangeable with grass pollen extracts labeled in AU/ml or with non-standardized grass pollen extracts. The recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml.       The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml."
    },
    {
      "NDCCode": "54575-093-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-093-02)",
      "NDC11Code": "54575-0093-02",
      "ProductNDC": "54575-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Blue Grama Grass",
      "NonProprietaryName": "Bouteloua Gracilis Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "BOUTELOUA GRACILIS POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-094-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-094-02)",
      "NDC11Code": "54575-0094-02",
      "ProductNDC": "54575-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Johnson Grass Pollen",
      "NonProprietaryName": "Sorghum Halepense Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "SORGHUM HALEPENSE POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-095-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-095-02)",
      "NDC11Code": "54575-0095-02",
      "ProductNDC": "54575-095",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tall Oat Grass Pollen",
      "NonProprietaryName": "Arrhenatherum Elatius Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "ARRHENATHERUM ELATIUS POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "54575-096-02",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-096-02)",
      "NDC11Code": "54575-0096-02",
      "ProductNDC": "54575-096",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cultivated Oats Pollen",
      "NonProprietaryName": "Avena Sativa Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19671207",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101376",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "AVENA SATIVA POLLEN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54575-398-02","ProprietaryName":"Grape","NonProprietaryName":"Concord Grape"},{"NDCCode":"54575-398-10","ProprietaryName":"Grape","NonProprietaryName":"Concord Grape"},{"NDCCode":"54575-398-30","ProprietaryName":"Grape","NonProprietaryName":"Concord Grape"},{"NDCCode":"54575-398-50","ProprietaryName":"Grape","NonProprietaryName":"Concord Grape"},{"NDCCode":"11673-398-02","ProprietaryName":"Hydrocortisone","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"49349-398-02","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"51346-398-02","ProprietaryName":"Snail Solu Tion","NonProprietaryName":"Dimethicone"},{"NDCCode":"61649-398-02","ProprietaryName":"Bio Spectra","NonProprietaryName":"Alcohol"},{"NDCCode":"63545-398-02","ProprietaryName":"Baryta Muriatica","NonProprietaryName":"Baryta Muriatica"},{"NDCCode":"68703-398-02","ProprietaryName":"Nativeremedies Tic Tamer","NonProprietaryName":"Chamomilla, Cina, Hyoscyamus, Zinc Met"},{"NDCCode":"69168-398-02","ProprietaryName":"Bisacodyl 5mg","NonProprietaryName":"Bisacodyl 5mg"},{"NDCCode":"72603-398-02","ProprietaryName":"Sevelamer Carbonate","NonProprietaryName":"Sevelamer Carbonate"},{"NDCCode":"84525-398-02","ProprietaryName":"Trstay Jasminum Esseatial Cream","NonProprietaryName":"Trstay Jasminum Esseatial Cream"},{"NDCCode":"84756-398-02","ProprietaryName":"Anti-aging Cream","NonProprietaryName":"Anti-aging Cream"},{"NDCCode":"84827-398-02","ProprietaryName":"Moustache Beard Oil","NonProprietaryName":"Moustache Beard Oil"},{"NDCCode":"54575-081-02","ProprietaryName":"Bahia Grass Pollen","NonProprietaryName":"Paspalum Notatum Pollen"},{"NDCCode":"54575-082-02","ProprietaryName":"Cultivated Barley Pollen","NonProprietaryName":"Hordeum Vulgare Pollen"},{"NDCCode":"54575-083-02","ProprietaryName":"Creeping Bent Grass Pollen","NonProprietaryName":"Agrostis Stolonifera Pollen"},{"NDCCode":"54575-084-02","ProprietaryName":"Standardized Bermuda Grass Pollen","NonProprietaryName":"Cynodon Dactylon Pollen"},{"NDCCode":"54575-085-02","ProprietaryName":"Annual Bluegrass Pollen","NonProprietaryName":"Poa Annua Pollen"},{"NDCCode":"54575-087-02","ProprietaryName":"Standardized Kentucky Bluegrass Pollen","NonProprietaryName":"Poa Pratensis Pollen"},{"NDCCode":"54575-088-02","ProprietaryName":"Hungarian Smooth Brome Pollen","NonProprietaryName":"Bromus Inermis Pollen"},{"NDCCode":"54575-089-02","ProprietaryName":"Canary Grass Pollen","NonProprietaryName":"Phalaris Minor Pollen"},{"NDCCode":"54575-090-02","ProprietaryName":"Southern Cheat Chess Pollen","NonProprietaryName":"Bromus Secalinus Pollen"},{"NDCCode":"54575-091-02","ProprietaryName":"Cultivated Corn Pollen","NonProprietaryName":"Zea Mays Pollen"},{"NDCCode":"54575-092-02","ProprietaryName":"Standardized Meadow Fescue Grass Pollen","NonProprietaryName":"Festuca Elatior Pollen"},{"NDCCode":"54575-093-02","ProprietaryName":"Blue Grama Grass","NonProprietaryName":"Bouteloua Gracilis Pollen"},{"NDCCode":"54575-094-02","ProprietaryName":"Johnson Grass Pollen","NonProprietaryName":"Sorghum Halepense Pollen"},{"NDCCode":"54575-095-02","ProprietaryName":"Tall Oat Grass Pollen","NonProprietaryName":"Arrhenatherum Elatius Pollen"},{"NDCCode":"54575-096-02","ProprietaryName":"Cultivated Oats Pollen","NonProprietaryName":"Avena Sativa Pollen"}]}
                    

<NDCList><NDC><NDCCode>54575-398-02</NDCCode><ProprietaryName>Grape</ProprietaryName><NonProprietaryName>Concord Grape</NonProprietaryName></NDC><NDC><NDCCode>54575-398-10</NDCCode><ProprietaryName>Grape</ProprietaryName><NonProprietaryName>Concord Grape</NonProprietaryName></NDC><NDC><NDCCode>54575-398-30</NDCCode><ProprietaryName>Grape</ProprietaryName><NonProprietaryName>Concord Grape</NonProprietaryName></NDC><NDC><NDCCode>54575-398-50</NDCCode><ProprietaryName>Grape</ProprietaryName><NonProprietaryName>Concord Grape</NonProprietaryName></NDC><NDC><NDCCode>11673-398-02</NDCCode><ProprietaryName>Hydrocortisone</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>49349-398-02</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>51346-398-02</NDCCode><ProprietaryName>Snail Solu Tion</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>61649-398-02</NDCCode><ProprietaryName>Bio Spectra</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>63545-398-02</NDCCode><ProprietaryName>Baryta Muriatica</ProprietaryName><NonProprietaryName>Baryta Muriatica</NonProprietaryName></NDC><NDC><NDCCode>68703-398-02</NDCCode><ProprietaryName>Nativeremedies Tic Tamer</ProprietaryName><NonProprietaryName>Chamomilla, Cina, Hyoscyamus, Zinc Met</NonProprietaryName></NDC><NDC><NDCCode>69168-398-02</NDCCode><ProprietaryName>Bisacodyl 5mg</ProprietaryName><NonProprietaryName>Bisacodyl 5mg</NonProprietaryName></NDC><NDC><NDCCode>72603-398-02</NDCCode><ProprietaryName>Sevelamer Carbonate</ProprietaryName><NonProprietaryName>Sevelamer Carbonate</NonProprietaryName></NDC><NDC><NDCCode>84525-398-02</NDCCode><ProprietaryName>Trstay Jasminum Esseatial Cream</ProprietaryName><NonProprietaryName>Trstay Jasminum Esseatial Cream</NonProprietaryName></NDC><NDC><NDCCode>84756-398-02</NDCCode><ProprietaryName>Anti-aging Cream</ProprietaryName><NonProprietaryName>Anti-aging Cream</NonProprietaryName></NDC><NDC><NDCCode>84827-398-02</NDCCode><ProprietaryName>Moustache Beard Oil</ProprietaryName><NonProprietaryName>Moustache Beard Oil</NonProprietaryName></NDC><NDC><NDCCode>54575-081-02</NDCCode><ProprietaryName>Bahia Grass Pollen</ProprietaryName><NonProprietaryName>Paspalum Notatum Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-082-02</NDCCode><ProprietaryName>Cultivated Barley Pollen</ProprietaryName><NonProprietaryName>Hordeum Vulgare Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-083-02</NDCCode><ProprietaryName>Creeping Bent Grass Pollen</ProprietaryName><NonProprietaryName>Agrostis Stolonifera Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-084-02</NDCCode><ProprietaryName>Standardized Bermuda Grass Pollen</ProprietaryName><NonProprietaryName>Cynodon Dactylon Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-085-02</NDCCode><ProprietaryName>Annual Bluegrass Pollen</ProprietaryName><NonProprietaryName>Poa Annua Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-087-02</NDCCode><ProprietaryName>Standardized Kentucky Bluegrass Pollen</ProprietaryName><NonProprietaryName>Poa Pratensis Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-088-02</NDCCode><ProprietaryName>Hungarian Smooth Brome Pollen</ProprietaryName><NonProprietaryName>Bromus Inermis Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-089-02</NDCCode><ProprietaryName>Canary Grass Pollen</ProprietaryName><NonProprietaryName>Phalaris Minor Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-090-02</NDCCode><ProprietaryName>Southern Cheat Chess Pollen</ProprietaryName><NonProprietaryName>Bromus Secalinus Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-091-02</NDCCode><ProprietaryName>Cultivated Corn Pollen</ProprietaryName><NonProprietaryName>Zea Mays Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-092-02</NDCCode><ProprietaryName>Standardized Meadow Fescue Grass Pollen</ProprietaryName><NonProprietaryName>Festuca Elatior Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-093-02</NDCCode><ProprietaryName>Blue Grama Grass</ProprietaryName><NonProprietaryName>Bouteloua Gracilis Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-094-02</NDCCode><ProprietaryName>Johnson Grass Pollen</ProprietaryName><NonProprietaryName>Sorghum Halepense Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-095-02</NDCCode><ProprietaryName>Tall Oat Grass Pollen</ProprietaryName><NonProprietaryName>Arrhenatherum Elatius Pollen</NonProprietaryName></NDC><NDC><NDCCode>54575-096-02</NDCCode><ProprietaryName>Cultivated Oats Pollen</ProprietaryName><NonProprietaryName>Avena Sativa Pollen</NonProprietaryName></NDC></NDCList>