RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "36987-1490-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1490-2)",
      "NDC11Code": "36987-1490-02",
      "ProductNDC": "36987-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "White Potato",
      "NonProprietaryName": "White Potato",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "POTATO",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1490-1",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1490-1)",
      "NDC11Code": "36987-1490-01",
      "ProductNDC": "36987-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "White Potato",
      "NonProprietaryName": "White Potato",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "POTATO",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1490-3",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1490-3)",
      "NDC11Code": "36987-1490-03",
      "ProductNDC": "36987-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "White Potato",
      "NonProprietaryName": "White Potato",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "POTATO",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1490-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1490-4)",
      "NDC11Code": "36987-1490-04",
      "ProductNDC": "36987-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "White Potato",
      "NonProprietaryName": "White Potato",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "POTATO",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "37662-1490-2",
      "PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-1490-2) ",
      "NDC11Code": "37662-1490-02",
      "ProductNDC": "37662-1490",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kali Iodatum",
      "NonProprietaryName": "Kali Iodatum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220912",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "POTASSIUM IODIDE",
      "StrengthNumber": "12",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-09-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220912",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64942-1490-2",
      "PackageDescription": "45 g in 1 CONTAINER (64942-1490-2)",
      "NDC11Code": "64942-1490-02",
      "ProductNDC": "64942-1490",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dove",
      "ProprietaryNameSuffix": "Advanced Care Cool Essentials Antiperspirant And Deodorant",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Conopco Inc. d/b/a Unilever",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "15.2",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "reduces underarm wetness."
    },
    {
      "NDCCode": "64942-1490-4",
      "PackageDescription": "2 CONTAINER in 1 PACKAGE (64942-1490-4)  > 74 g in 1 CONTAINER (64942-1490-1)",
      "NDC11Code": "64942-1490-04",
      "ProductNDC": "64942-1490",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dove",
      "ProprietaryNameSuffix": "Advanced Care Cool Essentials Antiperspirant And Deodorant",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Conopco Inc. d/b/a Unilever",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "15.2",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "reduces underarm wetness."
    },
    {
      "NDCCode": "71335-1490-2",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (71335-1490-2) ",
      "NDC11Code": "71335-1490-02",
      "ProductNDC": "71335-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151230",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090007",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200214",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin Capsules, USP are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
      "Description": "The active ingredient in Gabapentin Capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Capsules, USP contain 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: lactose monohydrate, corn starch, and talc. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue # 1 Aluminum Lake, propylene glycol, titanium dioxide and shellac."
    },
    {
      "NDCCode": "0078-1490-13",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (0078-1490-13)  / 10 TABLET in 1 BLISTER PACK (0078-1490-26) ",
      "NDC11Code": "00078-1490-13",
      "ProductNDC": "0078-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gleevec",
      "NonProprietaryName": "Imatinib Mesylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141223",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021588",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "IMATINIB MESYLATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gleevec is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
      "Description": "Imatinib is a small molecule kinase inhibitor. Gleevec film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O  CH4SO3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide (NF); crospovidone (NF); hydroxypropyl methylcellulose (USP); magnesium stearate (NF); and microcrystalline cellulose (NF). Tablet coating: ferric oxide, red (NF); ferric oxide, yellow (NF); hydroxypropyl methylcellulose (USP); polyethylene glycol (NF), and talc (USP)."
    },
    {
      "NDCCode": "0115-1490-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (0115-1490-01) ",
      "NDC11Code": "00115-1490-01",
      "ProductNDC": "0115-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076852",
      "LabelerName": "Amneal Pharmaceuticals of New York LLC",
      "SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
      "StrengthNumber": "6.25; 6.25; 6.25; 6.25",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160216",
      "SamplePackage": "N",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include corn starch, hypromellose type 2,910/3 cP, 5 cP, 6 cP and 50 cP, methacrylic acid copolymer type C, polydextrose, polyethylene glycol/macrogol, red iron oxide, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The capsule shells contain gelatin and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsule shells also contain FD&C Blue No. 1. The 20 mg, 25 mg and 30 mg capsule shells also contain black iron oxide, red iron oxide, and yellow iron oxide. Additionally, the capsule imprint ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "0781-1490-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-1490-01) ",
      "NDC11Code": "00781-1490-01",
      "ProductNDC": "0781-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amitriptyline Hydrochloride",
      "NonProprietaryName": "Amitriptyline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19771121",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA085968",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19771121",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
      "Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene-Δ5, γ-propylamine hydrochloride. It has the following structural formula. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The 10 mg also includes D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; 25 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake; 50 mg – FD&C Blue #2 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake; 75 mg – D&C Red #7 Calcium Lake and FD&C Blue #2 Aluminum Lake; 100 mg – D&C Red #30 Aluminum Lake and D&C Yellow #10 Aluminum Lake; 150 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake."
    },
    {
      "NDCCode": "22840-1490-1",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (22840-1490-1) ",
      "NDC11Code": "22840-1490-01",
      "ProductNDC": "22840-1490",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Bald Cypress Pollen",
      "NonProprietaryName": "Taxodium Distichum",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19810915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101833",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "TAXODIUM DISTICHUM POLLEN",
      "StrengthNumber": ".001",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19810915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
      "Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
    },
    {
      "NDCCode": "50090-1490-0",
      "PackageDescription": "473 mL in 1 BOTTLE (50090-1490-0) ",
      "NDC11Code": "50090-1490-00",
      "ProductNDC": "50090-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isoniazid",
      "NonProprietaryName": "Isoniazid",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19831111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088235",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "ISONIAZID",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Antimycobacterial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20141204",
      "SamplePackage": "N",
      "IndicationAndUsage": "Isoniazid oral solution is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication is inadequate therapy. Isoniazid oral solution is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.",
      "Description": "Isoniazid is an antibacterial available as an orange-flavored solution for oral administration containing 50 mg of Isoniazid USP per 5 mL of oral solution. Sorbitol solution USP (containing 70% Sorbitol) is used as the vehicle. This product also contains citric acid USP and potassium sorbate NF. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has a molecular formula of C6H7N3O and a molecular weight of 137.14. It has the following structural formula. Isoniazid is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light."
    },
    {
      "NDCCode": "51662-1490-1",
      "PackageDescription": "10 mL in 1 VIAL, SINGLE-DOSE (51662-1490-1) ",
      "NDC11Code": "51662-1490-01",
      "ProductNDC": "51662-1490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dopamine Hydrochloride",
      "NonProprietaryName": "Dopamine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210710",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207707",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "DOPAMINE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
      "Status": "Active",
      "LastUpdate": "2024-02-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210710",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dopamine Hydrochloride, USP is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Patients most likely to respond adequately to Dopamine Hydrochloride, USP are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with blood volume correction and Dopamine Hydrochloride, USP, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished prior to administration of Dopamine Hydrochloride, USP. Poor Perfusion of Vital Organs – Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored. Nevertheless, the physician should also observe the patient for signs of reversal of confusion or reversal of comatose condition. Loss of pallor, increase in toe temperature, and/or adequacy of nail bed capillary filling may also be used as indices of adequate dosage. Clinical studies have shown that when Dopamine Hydrochloride, USP is administered before urine flow has diminished to levels of approximately 0.3 mL/minute, prognosis is more favorable. Nevertheless, in a number of oliguric or anuric patients, administration of Dopamine Hydrochloride, USP has resulted in an increase in urine flow, which in some cases reached normal levels. Dopamine Hydrochloride, USP may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of pre-existing fluid accumulation. It should be noted that at doses above those optimal for the individual patient, urine flow may decrease, necessitating reduction of dosage. Low Cardiac Output – Increased cardiac output is related to dopamine’s direct inotropic effect on the myocardium. Increased cardiac output at low or moderate doses appears to be related to a favorable prognosis. Increase in cardiac output has been associated with either static or decreased systemic vascular resistance (SVR). Static or decreased SVR associated with low or moderate movements in cardiac output is believed to be a reflection of differential effects on specific vascular beds with increased resistance in peripheral beds (e.g., femoral) and concomitant decreases in mesenteric and renal vascular beds. Redistribution of blood flow parallels these changes so that an increase in cardiac output is accompanied by an increase in mesenteric and renal blood flow. In many instances the renal fraction of the total cardiac output has been found to increase. Increase in cardiac output produced by dopamine is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol. Hypotension – Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of Dopamine Hydrochloride, USP which have little effect on SVR. At high therapeutic doses, dopamine’s alpha-adrenergic activity becomes more prominent and thus may correct hypotension due to diminished SVR. As in the case of other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone profound deterioration. Therefore, it is suggested that the physician administer Dopamine Hydrochloride, USP as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.",
      "Description": "Dopamine Hydrochloride, USP a sympathomimetic amine vasopressor, is the naturally occurring immediate precursor of norepinephrine. Dopamine Hydrochloride, USP is a white to off-white crystalline powder, which may have a slight odor of hydrochloric acid. It is freely soluble in water and soluble in alcohol. Dopamine Hydrochloride, USP is sensitive to alkalies, iron salts, and oxidizing agents. Chemically it is designated as 4-(2-aminoethyl) pyrocatechol hydrochloride, and its molecular formula is C8H11NO2  HCl. The structural formula is. and the molecular weight is 189.64. Dopamine Hydrochloride Injection, USP is a clear, practically colorless, sterile, pyrogen-free, aqueous solution of Dopamine Hydrochloride, USP for intravenous infusion after dilution. Each milliliter of the 40 mg/mL preparation contains 40 mg of Dopamine Hydrochloride, USP (equivalent to 32.31 mg of dopamine base). Each milliliter of the 80 mg/mL preparation contains 80 mg of Dopamine Hydrochloride, USP (equivalent to 64.62 mg of dopamine base). Each milliliter of both preparations contains the following: Sodium metabisulfite 9 mg added as an antioxidant; citric acid, anhydrous 10 mg; and sodium citrate, dihydrate 5 mg added as a buffer. May contain additional citric acid and/or sodium citrate for pH adjustment. pH is 3.3 (2.5 to 5.0). Dopamine Hydrochloride Injection, USP must be diluted in an appropriate sterile parenteral solution before intravenous administration. (See DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "36987-1001-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1001-2)",
      "NDC11Code": "36987-1001-02",
      "ProductNDC": "36987-1001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cattle Epithelium",
      "NonProprietaryName": "Cattle Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BOS TAURUS SKIN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1002-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1002-2)",
      "NDC11Code": "36987-1002-02",
      "ProductNDC": "36987-1002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cattle Epithelium",
      "NonProprietaryName": "Cattle Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BOS TAURUS SKIN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1003-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1003-2)",
      "NDC11Code": "36987-1003-02",
      "ProductNDC": "36987-1003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cattle Epithelium",
      "NonProprietaryName": "Cattle Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BOS TAURUS SKIN",
      "StrengthNumber": "20000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1004-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1004-2)",
      "NDC11Code": "36987-1004-02",
      "ProductNDC": "36987-1004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cattle Epithelium",
      "NonProprietaryName": "Cattle Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BOS TAURUS SKIN",
      "StrengthNumber": "20000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1005-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1005-2)",
      "NDC11Code": "36987-1005-02",
      "ProductNDC": "36987-1005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cattle Epithelium",
      "NonProprietaryName": "Cattle Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BOS TAURUS SKIN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1006-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1006-2)",
      "NDC11Code": "36987-1006-02",
      "ProductNDC": "36987-1006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cattle Epithelium",
      "NonProprietaryName": "Cattle Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BOS TAURUS SKIN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1007-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1007-2)",
      "NDC11Code": "36987-1007-02",
      "ProductNDC": "36987-1007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cattle Epithelium",
      "NonProprietaryName": "Cattle Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BOS TAURUS SKIN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1008-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1008-2)",
      "NDC11Code": "36987-1008-02",
      "ProductNDC": "36987-1008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cattle Epithelium",
      "NonProprietaryName": "Cattle Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "BOS TAURUS SKIN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1009-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1009-2)",
      "NDC11Code": "36987-1009-02",
      "ProductNDC": "36987-1009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dog Epithelium",
      "NonProprietaryName": "Dog Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1010-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1010-2)",
      "NDC11Code": "36987-1010-02",
      "ProductNDC": "36987-1010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dog Epithelium",
      "NonProprietaryName": "Dog Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1011-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1011-2)",
      "NDC11Code": "36987-1011-02",
      "ProductNDC": "36987-1011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dog Epithelium",
      "NonProprietaryName": "Dog Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": "20000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1012-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1012-2)",
      "NDC11Code": "36987-1012-02",
      "ProductNDC": "36987-1012",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dog Epithelium",
      "NonProprietaryName": "Dog Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": "20000",
      "StrengthUnit": "[PNU]/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1013-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1013-2)",
      "NDC11Code": "36987-1013-02",
      "ProductNDC": "36987-1013",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dog Epithelium",
      "NonProprietaryName": "Dog Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1014-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1014-2)",
      "NDC11Code": "36987-1014-02",
      "ProductNDC": "36987-1014",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dog Epithelium",
      "NonProprietaryName": "Dog Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1015-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1015-2)",
      "NDC11Code": "36987-1015-02",
      "ProductNDC": "36987-1015",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dog Epithelium",
      "NonProprietaryName": "Dog Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1016-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1016-2)",
      "NDC11Code": "36987-1016-02",
      "ProductNDC": "36987-1016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dog Epithelium",
      "NonProprietaryName": "Dog Epithelium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    }
  ]
}
                    

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<NDCList><NDC><NDCCode>36987-1490-2</NDCCode><ProprietaryName>White Potato</ProprietaryName><NonProprietaryName>White Potato</NonProprietaryName></NDC><NDC><NDCCode>36987-1490-1</NDCCode><ProprietaryName>White Potato</ProprietaryName><NonProprietaryName>White Potato</NonProprietaryName></NDC><NDC><NDCCode>36987-1490-3</NDCCode><ProprietaryName>White Potato</ProprietaryName><NonProprietaryName>White Potato</NonProprietaryName></NDC><NDC><NDCCode>36987-1490-4</NDCCode><ProprietaryName>White Potato</ProprietaryName><NonProprietaryName>White Potato</NonProprietaryName></NDC><NDC><NDCCode>37662-1490-2</NDCCode><ProprietaryName>Kali Iodatum</ProprietaryName><NonProprietaryName>Kali Iodatum</NonProprietaryName></NDC><NDC><NDCCode>64942-1490-2</NDCCode><ProprietaryName>Dove</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>64942-1490-4</NDCCode><ProprietaryName>Dove</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>71335-1490-2</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>0078-1490-13</NDCCode><ProprietaryName>Gleevec</ProprietaryName><NonProprietaryName>Imatinib Mesylate</NonProprietaryName></NDC><NDC><NDCCode>0115-1490-01</NDCCode><ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0781-1490-01</NDCCode><ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName><NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>22840-1490-1</NDCCode><ProprietaryName>Bald Cypress Pollen</ProprietaryName><NonProprietaryName>Taxodium Distichum</NonProprietaryName></NDC><NDC><NDCCode>50090-1490-0</NDCCode><ProprietaryName>Isoniazid</ProprietaryName><NonProprietaryName>Isoniazid</NonProprietaryName></NDC><NDC><NDCCode>51662-1490-1</NDCCode><ProprietaryName>Dopamine Hydrochloride</ProprietaryName><NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>36987-1001-2</NDCCode><ProprietaryName>Cattle Epithelium</ProprietaryName><NonProprietaryName>Cattle Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1002-2</NDCCode><ProprietaryName>Cattle Epithelium</ProprietaryName><NonProprietaryName>Cattle Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1003-2</NDCCode><ProprietaryName>Cattle Epithelium</ProprietaryName><NonProprietaryName>Cattle Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1004-2</NDCCode><ProprietaryName>Cattle Epithelium</ProprietaryName><NonProprietaryName>Cattle Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1005-2</NDCCode><ProprietaryName>Cattle Epithelium</ProprietaryName><NonProprietaryName>Cattle Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1006-2</NDCCode><ProprietaryName>Cattle Epithelium</ProprietaryName><NonProprietaryName>Cattle Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1007-2</NDCCode><ProprietaryName>Cattle Epithelium</ProprietaryName><NonProprietaryName>Cattle Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1008-2</NDCCode><ProprietaryName>Cattle Epithelium</ProprietaryName><NonProprietaryName>Cattle Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1009-2</NDCCode><ProprietaryName>Dog Epithelium</ProprietaryName><NonProprietaryName>Dog Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1010-2</NDCCode><ProprietaryName>Dog Epithelium</ProprietaryName><NonProprietaryName>Dog Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1011-2</NDCCode><ProprietaryName>Dog Epithelium</ProprietaryName><NonProprietaryName>Dog Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1012-2</NDCCode><ProprietaryName>Dog Epithelium</ProprietaryName><NonProprietaryName>Dog Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1013-2</NDCCode><ProprietaryName>Dog Epithelium</ProprietaryName><NonProprietaryName>Dog Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1014-2</NDCCode><ProprietaryName>Dog Epithelium</ProprietaryName><NonProprietaryName>Dog Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1015-2</NDCCode><ProprietaryName>Dog Epithelium</ProprietaryName><NonProprietaryName>Dog Epithelium</NonProprietaryName></NDC><NDC><NDCCode>36987-1016-2</NDCCode><ProprietaryName>Dog Epithelium</ProprietaryName><NonProprietaryName>Dog Epithelium</NonProprietaryName></NDC></NDCList>