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How to Find 42021-035-11 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "42021-035-11",
      "PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (42021-035-11)  *  1 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION > 118 mL in 1 PACKAGE, COMBINATION *  1 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION > 50 mL in 1 PACKAGE, COMBINATION (42021-032-04)  *  1 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION > 150 mL in 1 PACKAGE, COMBINATION (42021-031-02) ",
      "NDC11Code": "42021-0035-11",
      "ProductNDC": "42021-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "3 Part Acne Treatment Kit",
      "ProprietaryNameSuffix": "Ceela Naturaals",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20171009",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "333D",
      "LabelerName": "Ceela Naturals, LLC",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20171009",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43419-035-16",
      "PackageDescription": "1 JAR in 1 CARTON (43419-035-16)  > 11 g in 1 JAR",
      "NDC11Code": "43419-0035-16",
      "ProductNDC": "43419-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sulwhasoo Evenfair Compact No.24",
      "NonProprietaryName": "Octinoxate And Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140205",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Amorepacific Corporation",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
      "StrengthNumber": ".22; 2.2",
      "StrengthUnit": "g/11g; g/11g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181105",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50268-035-15",
      "PackageDescription": "50 BLISTER PACK in 1 BOX (50268-035-15)  / 1 TABLET in 1 BLISTER PACK (50268-035-11) ",
      "NDC11Code": "50268-0035-15",
      "ProductNDC": "50268-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alprazolam",
      "NonProprietaryName": "Alprazolam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250825",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203346",
      "LabelerName": "AvPAK",
      "SubstanceName": "ALPRAZOLAM",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-09-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250825",
      "SamplePackage": "N",
      "IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
      "Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake."
    },
    {
      "NDCCode": "53747-035-00",
      "PackageDescription": "1 BAG in 1 DRUM (53747-035-00)  / 11 kg in 1 BAG",
      "NDC11Code": "53747-0035-00",
      "ProductNDC": "53747-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tolterodine Tartrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110929",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Unichem Laboratories Limited, India",
      "SubstanceName": "TOLTERODINE TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-16",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "29-SEP-11"
    },
    {
      "NDCCode": "61755-035-02",
      "PackageDescription": "1 KIT in 1 DOSE PACK (61755-035-02)  *  1 VIAL, GLASS in 1 CARTON (61755-024-01)  > 11.1 mL in 1 VIAL, GLASS (61755-024-00)  *  1 VIAL, GLASS in 1 CARTON (61755-025-01)  > 11.1 mL in 1 VIAL, GLASS (61755-025-00) ",
      "NDC11Code": "61755-0035-02",
      "ProductNDC": "61755-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Regen-cov",
      "NonProprietaryName": "Casirivimab And Imdevimab",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20210207",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Regeneron Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210207",
      "SamplePackage": "N",
      "IndicationAndUsage": "REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.",
      "Description": "Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0."
    },
    {
      "NDCCode": "62750-035-11",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (62750-035-11)  > 45 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC",
      "NDC11Code": "62750-0035-11",
      "ProductNDC": "62750-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zicam",
      "NonProprietaryName": "Zinc Acetate And Zinc Gluconate",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081107",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Matrixx Initiatives, Inc.",
      "SubstanceName": "ZINC ACETATE; ZINC GLUCONATE",
      "StrengthNumber": "2; 1",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-10-26"
    },
    {
      "NDCCode": "63776-035-11",
      "PackageDescription": ".5 mL in 1 AMPULE (63776-035-11) ",
      "NDC11Code": "63776-0035-11",
      "ProductNDC": "63776-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arthros",
      "NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell",
      "DosageFormName": "SPRAY",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120724",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "VIATREXX BIO INCORPORATED",
      "SubstanceName": ".ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN",
      "StrengthNumber": "30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30",
      "StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
      "Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70377-035-11",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-035-11) ",
      "NDC11Code": "70377-0035-11",
      "ProductNDC": "70377-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190128",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211020",
      "LabelerName": "Biocon Pharma Inc.,",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1   treatment of major depressive disorder (MDD) (1.1), 2   prevention of seasonal affective disorder (SAD) (1.2).",
      "Description": "Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg which are white to pale yellow round biconvex coated tablets imprinted with '188' and '189' in black ink on one side and plain on other side respectively. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opadry®(it contains hypromellose, tricetin and talc), opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14."
    },
    {
      "NDCCode": "72241-035-11",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (72241-035-11) ",
      "NDC11Code": "72241-0035-11",
      "ProductNDC": "72241-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nebivolol",
      "NonProprietaryName": "Nebivolol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208717",
      "LabelerName": "Modavar Pharmaceuticals LLC",
      "SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-11-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211218",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.(1.1).",
      "Description": "The chemical name for the active ingredient in nebivolol tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2' iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), polysorbate 80 and sodium lauryl sulfate."
    },
    {
      "NDCCode": "73069-035-11",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-035-11)  > 1 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "73069-0035-11",
      "ProductNDC": "73069-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Viatrexx-arthros",
      "NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
      "StartMarketingDate": "20190329",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "VIATREXX BIO INCORPORATED",
      "SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
      "StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31",
      "StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190506",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73212-035-11",
      "PackageDescription": "50 g in 1 BOTTLE (73212-035-11) ",
      "NDC11Code": "73212-0035-11",
      "ProductNDC": "73212-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Bromocriptine Mesylate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230102",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Qingdao Biopeptek Co., Ltd.",
      "SubstanceName": "BROMOCRIPTINE MESYLATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-12",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "02-JAN-23"
    },
    {
      "NDCCode": "83324-035-12",
      "PackageDescription": "1 TUBE in 1 CARTON (83324-035-12)  / 11.9 g in 1 TUBE",
      "NDC11Code": "83324-0035-12",
      "ProductNDC": "83324-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Quality Choice Oral Pain Relief",
      "NonProprietaryName": "Benzocaine 20%, Benzalkonium Chloride 1%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M022",
      "LabelerName": "Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)",
      "SubstanceName": "BENZOCAINE; BENZALKONIUM CHLORIDE",
      "StrengthNumber": "200; 10",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240401",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of pain due to toothaches. to help protect against infection in minor oral irritation."
    },
    {
      "NDCCode": "83511-035-11",
      "PackageDescription": ".01 kg in 1 DRUM (83511-035-11) ",
      "NDC11Code": "83511-0035-11",
      "ProductNDC": "83511-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Methylnaltrexone Bromide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20250929",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "STHREE CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "METHYLNALTREXONE BROMIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-08",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "29-SEP-25"
    },
    {
      "NDCCode": "84168-035-11",
      "PackageDescription": "12 g in 1 BOX (84168-035-11) ",
      "NDC11Code": "84168-0035-11",
      "ProductNDC": "84168-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fuhop Fungal Nail Patches",
      "NonProprietaryName": "Fungal Nail Patches",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240707",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Gaozhou Chapin Technology Co., Ltd",
      "SubstanceName": "TOLNAFTATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240707",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use for fungal nail infections."
    },
    {
      "NDCCode": "85207-035-11",
      "PackageDescription": "5000 g in 1 BAG (85207-035-11) ",
      "NDC11Code": "85207-0035-11",
      "ProductNDC": "85207-035",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Semax Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20260223",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "SCH Global Services Private Limited",
      "SubstanceName": "SEMAX",
      "StrengthNumber": "100",
      "StrengthUnit": "g/100g",
      "Status": "Unfinished",
      "LastUpdate": "2026-06-02",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "23-FEB-26"
    },
    {
      "NDCCode": "0409-3613-01",
      "PackageDescription": "10 AMPULE in 1 CARTON (0409-3613-01)  / 2 mL in 1 AMPULE (0409-3613-11) ",
      "NDC11Code": "00409-3613-01",
      "ProductNDC": "0409-3613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine",
      "ProprietaryNameSuffix": "Spinal",
      "NonProprietaryName": "Bupivacaine Hydrochloride In Dextrose",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBARACHNOID",
      "StartMarketingDate": "20050131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071810",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20050131",
      "SamplePackage": "N",
      "IndicationAndUsage": "BUPIVACAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).",
      "Description": "BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for BUPIVACAINE SPINAL is by subarachnoid injection. BUPIVACAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O·HCl·H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of BUPIVACAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. BUPIVACAINE SPINAL pH is between 4.0 and 6.5. The specific gravity of BUPIVACAINE SPINAL is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. BUPIVACAINE SPINAL does not contain any preservatives."
    },
    {
      "NDCCode": "10019-035-74",
      "PackageDescription": "5 AMPULE in 1 PACKAGE (10019-035-74)  > 20 mL in 1 AMPULE (10019-035-39)",
      "NDC11Code": "10019-0035-74",
      "ProductNDC": "10019-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fentanyl Citrate",
      "NonProprietaryName": "Fentanyl Citrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20100625",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA019101",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "FENTANYL CITRATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "11410-150-11",
      "PackageDescription": "30 mL in 1 TUBE (11410-150-11)",
      "NDC11Code": "11410-0150-11",
      "ProductNDC": "11410-150",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jane Seymour Natural Advantage",
      "ProprietaryNameSuffix": "Am Spf 15 All Day Moisture With Ahas",
      "NonProprietaryName": "Octinoxate, Oxybenzone, And Octisalate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20050426",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Guthy-Renker LLC",
      "SubstanceName": "OCTINOXATE; OXYBENZONE; OCTISALATE",
      "StrengthNumber": ".075; .04; .035",
      "StrengthUnit": "mL/mL; mg/mL; mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "11559-035-01",
      "PackageDescription": "1 CONTAINER in 1 CARTON (11559-035-01)  > 50 mL in 1 CONTAINER",
      "NDC11Code": "11559-0035-01",
      "ProductNDC": "11559-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Advanced Time Zone Age Reversing",
      "ProprietaryNameSuffix": "Line/wrinkle Oil Free Broad Spectrum Spf 15 Normal/combination Skin",
      "NonProprietaryName": "Avobenzone, Octinoxate, And Octisalate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130501",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "ESTEE LAUDER INC",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE",
      "StrengthNumber": ".03; .075; .05",
      "StrengthUnit": "g/mL; g/mL; g/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20130501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "14783-013-11",
      "PackageDescription": "1 CONTAINER in 1 CARTON (14783-013-11)  > 10 g in 1 CONTAINER (14783-013-10)",
      "NDC11Code": "14783-0013-11",
      "ProductNDC": "14783-013",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel",
      "ProprietaryNameSuffix": "Effet Parfait Mineral",
      "NonProprietaryName": "Titanium Dioxide, Oxybenzone, Zinc Oxide, And Octinoxate",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101215",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International, Limited",
      "SubstanceName": "TITANIUM DIOXIDE; OXYBENZONE; ZINC OXIDE; OCTINOXATE",
      "StrengthNumber": ".06; .05; .049; .035",
      "StrengthUnit": "g/g; g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn."
    },
    {
      "NDCCode": "16110-035-12",
      "PackageDescription": "1 TUBE in 1 CARTON (16110-035-12)  / 120 g in 1 TUBE",
      "NDC11Code": "16110-0035-12",
      "ProductNDC": "16110-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cordran",
      "NonProprietaryName": "Flurandrenolide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19651018",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA012806",
      "LabelerName": "Almirall, LLC",
      "SubstanceName": "FLURANDRENOLIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19651018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "16110-035-60",
      "PackageDescription": "1 TUBE in 1 CARTON (16110-035-60)  / 60 g in 1 TUBE",
      "NDC11Code": "16110-0035-60",
      "ProductNDC": "16110-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cordran",
      "NonProprietaryName": "Flurandrenolide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19651018",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA012806",
      "LabelerName": "Almirall, LLC",
      "SubstanceName": "FLURANDRENOLIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19651018",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
    },
    {
      "NDCCode": "21695-857-01",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (21695-857-01)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "21695-0857-01",
      "ProductNDC": "21695-857",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Necon",
      "NonProprietaryName": "Norethindrone And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19870129",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070687",
      "LabelerName": "Rebel Distributors Corp",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Necon® 1/35, Necon® 0.5/35, Necon® 10/11, and Necon® 1/50 are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
      "Description": "Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. Necon® 1/35: Each dark yellow tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 1/35 package contains only inert ingredients as follows: microcrystalline cellulose, lactose (anhydrous), and magnesium stearate. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yn-3,17-diol, and for mestranol is 3-methoxy-19-nor-17α-pregna-1,3,5(10)-trien-20-yn-17-ol. The structural formulas are as follows."
    },
    {
      "NDCCode": "24909-035-44",
      "PackageDescription": "44 g in 1 JAR (24909-035-44) ",
      "NDC11Code": "24909-0035-44",
      "ProductNDC": "24909-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Terrasil Bed Sore And Pressure Sore Relief",
      "NonProprietaryName": "Allantoin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions",
      "SubstanceName": "ALLANTOIN",
      "StrengthNumber": ".6",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent, temporarily protect, and relieve chapped or cracked skin."
    },
    {
      "NDCCode": "24909-035-45",
      "PackageDescription": "44 g in 1 TUBE (24909-035-45) ",
      "NDC11Code": "24909-0035-45",
      "ProductNDC": "24909-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Terrasil Bed Sore And Pressure Sore Relief",
      "NonProprietaryName": "Allantoin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions",
      "SubstanceName": "ALLANTOIN",
      "StrengthNumber": ".6",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-11-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent, temporarily protect, and relieve chapped or cracked skin."
    },
    {
      "NDCCode": "24909-035-85",
      "PackageDescription": "85 g in 1 TUBE (24909-035-85) ",
      "NDC11Code": "24909-0035-85",
      "ProductNDC": "24909-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Terrasil Bed Sore And Pressure Sore Relief",
      "NonProprietaryName": "Allantoin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions",
      "SubstanceName": "ALLANTOIN",
      "StrengthNumber": ".6",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent, temporarily protect, and relieve chapped or cracked skin."
    },
    {
      "NDCCode": "31722-035-23",
      "PackageDescription": "236.5 mL in 1 BOTTLE, PLASTIC (31722-035-23) ",
      "NDC11Code": "31722-0035-23",
      "ProductNDC": "31722-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aminocaproic Acid",
      "NonProprietaryName": "Aminocaproic Acid",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216464",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "AMINOCAPROIC ACID",
      "StrengthNumber": ".25",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
      "Status": "Active",
      "LastUpdate": "2022-11-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).",
      "Description": "Aminocaproic acid, USP is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is freely soluble in water, 0.1N hydrochloric acid, soluble in 0.1N sodium hydroxide. Slightly soluble in methanol, practically insoluble in chloroform and in diethyl ether. Aminocaproic acid oral solution, USP for oral administration, contains 0.25 g/mL of aminocaproic acid, USP with methylparaben 0.20%, propylparaben 0.05%, edetate disodium dihydrate 0.30% as preservatives and the following inactive ingredients: anhydrous citric acid, purified water, raspberry flavor, saccharin sodium and sorbitol solution."
    },
    {
      "NDCCode": "33342-035-06",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (33342-035-06)  / 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "33342-0035-06",
      "ProductNDC": "33342-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120921",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202164",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120921",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. ·  Parkinson’s disease (PD) (1.1)   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
      "Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate."
    },
    {
      "NDCCode": "33342-035-10",
      "PackageDescription": "90 TABLET in 1 BOTTLE (33342-035-10) ",
      "NDC11Code": "33342-0035-10",
      "ProductNDC": "33342-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120921",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202164",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120921",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. ·  Parkinson’s disease (PD) (1.1)   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
      "Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate."
    },
    {
      "NDCCode": "33342-035-12",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (33342-035-12)  / 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "33342-0035-12",
      "ProductNDC": "33342-035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120921",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202164",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120921",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. ·  Parkinson’s disease (PD) (1.1)   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
      "Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"42021-035-11","ProprietaryName":"3 Part Acne Treatment Kit","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"43419-035-16","ProprietaryName":"Sulwhasoo Evenfair Compact No.24","NonProprietaryName":"Octinoxate And Titanium Dioxide"},{"NDCCode":"50268-035-15","ProprietaryName":"Alprazolam","NonProprietaryName":"Alprazolam"},{"NDCCode":"53747-035-00","NonProprietaryName":"Tolterodine Tartrate"},{"NDCCode":"61755-035-02","ProprietaryName":"Regen-cov","NonProprietaryName":"Casirivimab And Imdevimab"},{"NDCCode":"62750-035-11","ProprietaryName":"Zicam","NonProprietaryName":"Zinc Acetate And Zinc Gluconate"},{"NDCCode":"63776-035-11","ProprietaryName":"Arthros","NonProprietaryName":"Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell"},{"NDCCode":"70377-035-11","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Bupropion Hydrochloride"},{"NDCCode":"72241-035-11","ProprietaryName":"Nebivolol","NonProprietaryName":"Nebivolol"},{"NDCCode":"73069-035-11","ProprietaryName":"Viatrexx-arthros","NonProprietaryName":"Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein"},{"NDCCode":"73212-035-11","NonProprietaryName":"Bromocriptine Mesylate"},{"NDCCode":"83324-035-12","ProprietaryName":"Quality Choice Oral Pain Relief","NonProprietaryName":"Benzocaine 20%, Benzalkonium Chloride 1%"},{"NDCCode":"83511-035-11","NonProprietaryName":"Methylnaltrexone Bromide"},{"NDCCode":"84168-035-11","ProprietaryName":"Fuhop Fungal Nail Patches","NonProprietaryName":"Fungal Nail Patches"},{"NDCCode":"85207-035-11","NonProprietaryName":"Semax Acetate"},{"NDCCode":"0409-3613-01","ProprietaryName":"Bupivacaine","NonProprietaryName":"Bupivacaine Hydrochloride In Dextrose"},{"NDCCode":"10019-035-74","ProprietaryName":"Fentanyl Citrate","NonProprietaryName":"Fentanyl Citrate"},{"NDCCode":"11410-150-11","ProprietaryName":"Jane Seymour Natural Advantage","NonProprietaryName":"Octinoxate, Oxybenzone, And Octisalate"},{"NDCCode":"11559-035-01","ProprietaryName":"Advanced Time Zone Age Reversing","NonProprietaryName":"Avobenzone, Octinoxate, And Octisalate"},{"NDCCode":"14783-013-11","ProprietaryName":"Lbel","NonProprietaryName":"Titanium Dioxide, Oxybenzone, Zinc Oxide, And Octinoxate"},{"NDCCode":"16110-035-12","ProprietaryName":"Cordran","NonProprietaryName":"Flurandrenolide"},{"NDCCode":"16110-035-60","ProprietaryName":"Cordran","NonProprietaryName":"Flurandrenolide"},{"NDCCode":"21695-857-01","ProprietaryName":"Necon","NonProprietaryName":"Norethindrone And Ethinyl Estradiol"},{"NDCCode":"24909-035-44","ProprietaryName":"Terrasil Bed Sore And Pressure Sore Relief","NonProprietaryName":"Allantoin"},{"NDCCode":"24909-035-45","ProprietaryName":"Terrasil Bed Sore And Pressure Sore Relief","NonProprietaryName":"Allantoin"},{"NDCCode":"24909-035-85","ProprietaryName":"Terrasil Bed Sore And Pressure Sore Relief","NonProprietaryName":"Allantoin"},{"NDCCode":"31722-035-23","ProprietaryName":"Aminocaproic Acid","NonProprietaryName":"Aminocaproic Acid"},{"NDCCode":"33342-035-06","ProprietaryName":"Pramipexole Dihydrochloride","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"33342-035-10","ProprietaryName":"Pramipexole Dihydrochloride","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"33342-035-12","ProprietaryName":"Pramipexole Dihydrochloride","NonProprietaryName":"Pramipexole Dihydrochloride"}]}
                    
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<NDCList>
  <NDC>
    <NDCCode>42021-035-11</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (42021-035-11)  *  1 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION &gt; 118 mL in 1 PACKAGE, COMBINATION *  1 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION &gt; 50 mL in 1 PACKAGE, COMBINATION (42021-032-04)  *  1 PACKAGE, COMBINATION in 1 PACKAGE, COMBINATION &gt; 150 mL in 1 PACKAGE, COMBINATION (42021-031-02) </PackageDescription>
    <NDC11Code>42021-0035-11</NDC11Code>
    <ProductNDC>42021-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>3 Part Acne Treatment Kit</ProprietaryName>
    <ProprietaryNameSuffix>Ceela Naturaals</ProprietaryNameSuffix>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20171009</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>333D</ApplicationNumber>
    <LabelerName>Ceela Naturals, LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171009</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>43419-035-16</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (43419-035-16)  &gt; 11 g in 1 JAR</PackageDescription>
    <NDC11Code>43419-0035-16</NDC11Code>
    <ProductNDC>43419-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sulwhasoo Evenfair Compact No.24</ProprietaryName>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
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    <StartMarketingDate>20140205</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Amorepacific Corporation</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>.22; 2.2</StrengthNumber>
    <StrengthUnit>g/11g; g/11g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50268-035-15</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOX (50268-035-15)  / 1 TABLET in 1 BLISTER PACK (50268-035-11) </PackageDescription>
    <NDC11Code>50268-0035-15</NDC11Code>
    <ProductNDC>50268-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250825</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203346</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250825</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&amp;C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&amp;C Blue No. 2 lake.</Description>
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  <NDC>
    <NDCCode>53747-035-00</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (53747-035-00)  / 11 kg in 1 BAG</PackageDescription>
    <NDC11Code>53747-0035-00</NDC11Code>
    <ProductNDC>53747-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110929</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Unichem Laboratories Limited, India</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-16</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-SEP-11</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>61755-035-02</NDCCode>
    <PackageDescription>1 KIT in 1 DOSE PACK (61755-035-02)  *  1 VIAL, GLASS in 1 CARTON (61755-024-01)  &gt; 11.1 mL in 1 VIAL, GLASS (61755-024-00)  *  1 VIAL, GLASS in 1 CARTON (61755-025-01)  &gt; 11.1 mL in 1 VIAL, GLASS (61755-025-00) </PackageDescription>
    <NDC11Code>61755-0035-02</NDC11Code>
    <ProductNDC>61755-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Regen-cov</ProprietaryName>
    <NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210207</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.</IndicationAndUsage>
    <Description>Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa. Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex. : 1 Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0., 2 Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.</Description>
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  <NDC>
    <NDCCode>62750-035-11</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (62750-035-11)  &gt; 45 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>62750-0035-11</NDC11Code>
    <ProductNDC>62750-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zicam</ProprietaryName>
    <NonProprietaryName>Zinc Acetate And Zinc Gluconate</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081107</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Matrixx Initiatives, Inc.</LabelerName>
    <SubstanceName>ZINC ACETATE; ZINC GLUCONATE</SubstanceName>
    <StrengthNumber>2; 1</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-10-26</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>63776-035-11</NDCCode>
    <PackageDescription>.5 mL in 1 AMPULE (63776-035-11) </PackageDescription>
    <NDC11Code>63776-0035-11</NDC11Code>
    <ProductNDC>63776-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arthros</ProprietaryName>
    <NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120724</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
    <SubstanceName>.ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN</SubstanceName>
    <StrengthNumber>30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30</StrengthNumber>
    <StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70377-035-11</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-035-11) </PackageDescription>
    <NDC11Code>70377-0035-11</NDC11Code>
    <ProductNDC>70377-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190128</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211020</ApplicationNumber>
    <LabelerName>Biocon Pharma Inc.,</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1   treatment of major depressive disorder (MDD) (1.1), 2   prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
    <Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg which are white to pale yellow round biconvex coated tablets imprinted with '188' and '189' in black ink on one side and plain on other side respectively. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opadry®(it contains hypromellose, tricetin and talc), opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
  </NDC>
  <NDC>
    <NDCCode>72241-035-11</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (72241-035-11) </PackageDescription>
    <NDC11Code>72241-0035-11</NDC11Code>
    <ProductNDC>72241-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nebivolol</ProprietaryName>
    <NonProprietaryName>Nebivolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208717</ApplicationNumber>
    <LabelerName>Modavar Pharmaceuticals LLC</LabelerName>
    <SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.(1.1).</IndicationAndUsage>
    <Description>The chemical name for the active ingredient in nebivolol tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2' iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), polysorbate 80 and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>73069-035-11</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-035-11)  &gt; 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>73069-0035-11</NDC11Code>
    <ProductNDC>73069-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Viatrexx-arthros</ProprietaryName>
    <NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
    <SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
    <StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
    <StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73212-035-11</NDCCode>
    <PackageDescription>50 g in 1 BOTTLE (73212-035-11) </PackageDescription>
    <NDC11Code>73212-0035-11</NDC11Code>
    <ProductNDC>73212-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230102</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
    <SubstanceName>BROMOCRIPTINE MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-12</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83324-035-12</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (83324-035-12)  / 11.9 g in 1 TUBE</PackageDescription>
    <NDC11Code>83324-0035-12</NDC11Code>
    <ProductNDC>83324-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Quality Choice Oral Pain Relief</ProprietaryName>
    <NonProprietaryName>Benzocaine 20%, Benzalkonium Chloride 1%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M022</ApplicationNumber>
    <LabelerName>Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)</LabelerName>
    <SubstanceName>BENZOCAINE; BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>200; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of pain due to toothaches. to help protect against infection in minor oral irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83511-035-11</NDCCode>
    <PackageDescription>.01 kg in 1 DRUM (83511-035-11) </PackageDescription>
    <NDC11Code>83511-0035-11</NDC11Code>
    <ProductNDC>83511-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20250929</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>STHREE CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>METHYLNALTREXONE BROMIDE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-08</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-SEP-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>84168-035-11</NDCCode>
    <PackageDescription>12 g in 1 BOX (84168-035-11) </PackageDescription>
    <NDC11Code>84168-0035-11</NDC11Code>
    <ProductNDC>84168-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fuhop Fungal Nail Patches</ProprietaryName>
    <NonProprietaryName>Fungal Nail Patches</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240707</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Gaozhou Chapin Technology Co., Ltd</LabelerName>
    <SubstanceName>TOLNAFTATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use for fungal nail infections.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85207-035-11</NDCCode>
    <PackageDescription>5000 g in 1 BAG (85207-035-11) </PackageDescription>
    <NDC11Code>85207-0035-11</NDC11Code>
    <ProductNDC>85207-035</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Semax Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20260223</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>SCH Global Services Private Limited</LabelerName>
    <SubstanceName>SEMAX</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>23-FEB-26</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0409-3613-01</NDCCode>
    <PackageDescription>10 AMPULE in 1 CARTON (0409-3613-01)  / 2 mL in 1 AMPULE (0409-3613-11) </PackageDescription>
    <NDC11Code>00409-3613-01</NDC11Code>
    <ProductNDC>0409-3613</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupivacaine</ProprietaryName>
    <ProprietaryNameSuffix>Spinal</ProprietaryNameSuffix>
    <NonProprietaryName>Bupivacaine Hydrochloride In Dextrose</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBARACHNOID</RouteName>
    <StartMarketingDate>20050131</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071810</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BUPIVACAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).</IndicationAndUsage>
    <Description>BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for BUPIVACAINE SPINAL is by subarachnoid injection. BUPIVACAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C18H28N2O·HCl·H2O and molecular weight of 342.90 g/mol and has the following structural formula. Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula. BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of BUPIVACAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. BUPIVACAINE SPINAL pH is between 4.0 and 6.5. The specific gravity of BUPIVACAINE SPINAL is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. BUPIVACAINE SPINAL does not contain any preservatives.</Description>
  </NDC>
  <NDC>
    <NDCCode>10019-035-74</NDCCode>
    <PackageDescription>5 AMPULE in 1 PACKAGE (10019-035-74)  &gt; 20 mL in 1 AMPULE (10019-035-39)</PackageDescription>
    <NDC11Code>10019-0035-74</NDC11Code>
    <ProductNDC>10019-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fentanyl Citrate</ProprietaryName>
    <NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20100625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA019101</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>FENTANYL CITRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11410-150-11</NDCCode>
    <PackageDescription>30 mL in 1 TUBE (11410-150-11)</PackageDescription>
    <NDC11Code>11410-0150-11</NDC11Code>
    <ProductNDC>11410-150</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jane Seymour Natural Advantage</ProprietaryName>
    <ProprietaryNameSuffix>Am Spf 15 All Day Moisture With Ahas</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Oxybenzone, And Octisalate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20050426</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Guthy-Renker LLC</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE; OCTISALATE</SubstanceName>
    <StrengthNumber>.075; .04; .035</StrengthNumber>
    <StrengthUnit>mL/mL; mg/mL; mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11559-035-01</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (11559-035-01)  &gt; 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>11559-0035-01</NDC11Code>
    <ProductNDC>11559-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advanced Time Zone Age Reversing</ProprietaryName>
    <ProprietaryNameSuffix>Line/wrinkle Oil Free Broad Spectrum Spf 15 Normal/combination Skin</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octinoxate, And Octisalate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ESTEE LAUDER INC</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE</SubstanceName>
    <StrengthNumber>.03; .075; .05</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>14783-013-11</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (14783-013-11)  &gt; 10 g in 1 CONTAINER (14783-013-10)</PackageDescription>
    <NDC11Code>14783-0013-11</NDC11Code>
    <ProductNDC>14783-013</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel</ProprietaryName>
    <ProprietaryNameSuffix>Effet Parfait Mineral</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide, Oxybenzone, Zinc Oxide, And Octinoxate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International, Limited</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OXYBENZONE; ZINC OXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>.06; .05; .049; .035</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16110-035-12</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (16110-035-12)  / 120 g in 1 TUBE</PackageDescription>
    <NDC11Code>16110-0035-12</NDC11Code>
    <ProductNDC>16110-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cordran</ProprietaryName>
    <NonProprietaryName>Flurandrenolide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19651018</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA012806</ApplicationNumber>
    <LabelerName>Almirall, LLC</LabelerName>
    <SubstanceName>FLURANDRENOLIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19651018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>16110-035-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (16110-035-60)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>16110-0035-60</NDC11Code>
    <ProductNDC>16110-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cordran</ProprietaryName>
    <NonProprietaryName>Flurandrenolide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19651018</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA012806</ApplicationNumber>
    <LabelerName>Almirall, LLC</LabelerName>
    <SubstanceName>FLURANDRENOLIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19651018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-857-01</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (21695-857-01)  &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21695-0857-01</NDC11Code>
    <ProductNDC>21695-857</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Necon</ProprietaryName>
    <NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19870129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070687</ApplicationNumber>
    <LabelerName>Rebel Distributors Corp</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Necon® 1/35, Necon® 0.5/35, Necon® 10/11, and Necon® 1/50 are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
    <Description>Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. Necon® 1/35: Each dark yellow tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&amp;C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 1/35 package contains only inert ingredients as follows: microcrystalline cellulose, lactose (anhydrous), and magnesium stearate. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yn-3,17-diol, and for mestranol is 3-methoxy-19-nor-17α-pregna-1,3,5(10)-trien-20-yn-17-ol. The structural formulas are as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>24909-035-44</NDCCode>
    <PackageDescription>44 g in 1 JAR (24909-035-44) </PackageDescription>
    <NDC11Code>24909-0035-44</NDC11Code>
    <ProductNDC>24909-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Terrasil Bed Sore And Pressure Sore Relief</ProprietaryName>
    <NonProprietaryName>Allantoin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Aidance Scientific, Inc, DBA Aidance Skincare &amp; Topical Solutions</LabelerName>
    <SubstanceName>ALLANTOIN</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent, temporarily protect, and relieve chapped or cracked skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24909-035-45</NDCCode>
    <PackageDescription>44 g in 1 TUBE (24909-035-45) </PackageDescription>
    <NDC11Code>24909-0035-45</NDC11Code>
    <ProductNDC>24909-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Terrasil Bed Sore And Pressure Sore Relief</ProprietaryName>
    <NonProprietaryName>Allantoin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Aidance Scientific, Inc, DBA Aidance Skincare &amp; Topical Solutions</LabelerName>
    <SubstanceName>ALLANTOIN</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent, temporarily protect, and relieve chapped or cracked skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24909-035-85</NDCCode>
    <PackageDescription>85 g in 1 TUBE (24909-035-85) </PackageDescription>
    <NDC11Code>24909-0035-85</NDC11Code>
    <ProductNDC>24909-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Terrasil Bed Sore And Pressure Sore Relief</ProprietaryName>
    <NonProprietaryName>Allantoin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Aidance Scientific, Inc, DBA Aidance Skincare &amp; Topical Solutions</LabelerName>
    <SubstanceName>ALLANTOIN</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent, temporarily protect, and relieve chapped or cracked skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31722-035-23</NDCCode>
    <PackageDescription>236.5 mL in 1 BOTTLE, PLASTIC (31722-035-23) </PackageDescription>
    <NDC11Code>31722-0035-23</NDC11Code>
    <ProductNDC>31722-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aminocaproic Acid</ProprietaryName>
    <NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216464</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMINOCAPROIC ACID</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).</IndicationAndUsage>
    <Description>Aminocaproic acid, USP is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is freely soluble in water, 0.1N hydrochloric acid, soluble in 0.1N sodium hydroxide. Slightly soluble in methanol, practically insoluble in chloroform and in diethyl ether. Aminocaproic acid oral solution, USP for oral administration, contains 0.25 g/mL of aminocaproic acid, USP with methylparaben 0.20%, propylparaben 0.05%, edetate disodium dihydrate 0.30% as preservatives and the following inactive ingredients: anhydrous citric acid, purified water, raspberry flavor, saccharin sodium and sorbitol solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-035-06</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (33342-035-06)  / 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0035-06</NDC11Code>
    <ProductNDC>33342-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120921</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202164</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. ·  Parkinson’s disease (PD) (1.1)   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-035-10</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (33342-035-10) </PackageDescription>
    <NDC11Code>33342-0035-10</NDC11Code>
    <ProductNDC>33342-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120921</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202164</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. ·  Parkinson’s disease (PD) (1.1)   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-035-12</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (33342-035-12)  / 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0035-12</NDC11Code>
    <ProductNDC>33342-035</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120921</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202164</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. ·  Parkinson’s disease (PD) (1.1)   Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>42021-035-11</NDCCode><ProprietaryName>3 Part Acne Treatment Kit</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>43419-035-16</NDCCode><ProprietaryName>Sulwhasoo Evenfair Compact No.24</ProprietaryName><NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>50268-035-15</NDCCode><ProprietaryName>Alprazolam</ProprietaryName><NonProprietaryName>Alprazolam</NonProprietaryName></NDC><NDC><NDCCode>53747-035-00</NDCCode><NonProprietaryName>Tolterodine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>61755-035-02</NDCCode><ProprietaryName>Regen-cov</ProprietaryName><NonProprietaryName>Casirivimab And Imdevimab</NonProprietaryName></NDC><NDC><NDCCode>62750-035-11</NDCCode><ProprietaryName>Zicam</ProprietaryName><NonProprietaryName>Zinc Acetate And Zinc Gluconate</NonProprietaryName></NDC><NDC><NDCCode>63776-035-11</NDCCode><ProprietaryName>Arthros</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell</NonProprietaryName></NDC><NDC><NDCCode>70377-035-11</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72241-035-11</NDCCode><ProprietaryName>Nebivolol</ProprietaryName><NonProprietaryName>Nebivolol</NonProprietaryName></NDC><NDC><NDCCode>73069-035-11</NDCCode><ProprietaryName>Viatrexx-arthros</ProprietaryName><NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName></NDC><NDC><NDCCode>73212-035-11</NDCCode><NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>83324-035-12</NDCCode><ProprietaryName>Quality Choice Oral Pain Relief</ProprietaryName><NonProprietaryName>Benzocaine 20%, Benzalkonium Chloride 1%</NonProprietaryName></NDC><NDC><NDCCode>83511-035-11</NDCCode><NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName></NDC><NDC><NDCCode>84168-035-11</NDCCode><ProprietaryName>Fuhop Fungal Nail Patches</ProprietaryName><NonProprietaryName>Fungal Nail Patches</NonProprietaryName></NDC><NDC><NDCCode>85207-035-11</NDCCode><NonProprietaryName>Semax Acetate</NonProprietaryName></NDC><NDC><NDCCode>0409-3613-01</NDCCode><ProprietaryName>Bupivacaine</ProprietaryName><NonProprietaryName>Bupivacaine Hydrochloride In Dextrose</NonProprietaryName></NDC><NDC><NDCCode>10019-035-74</NDCCode><ProprietaryName>Fentanyl Citrate</ProprietaryName><NonProprietaryName>Fentanyl Citrate</NonProprietaryName></NDC><NDC><NDCCode>11410-150-11</NDCCode><ProprietaryName>Jane Seymour Natural Advantage</ProprietaryName><NonProprietaryName>Octinoxate, Oxybenzone, And Octisalate</NonProprietaryName></NDC><NDC><NDCCode>11559-035-01</NDCCode><ProprietaryName>Advanced Time Zone Age Reversing</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, And Octisalate</NonProprietaryName></NDC><NDC><NDCCode>14783-013-11</NDCCode><ProprietaryName>Lbel</ProprietaryName><NonProprietaryName>Titanium Dioxide, Oxybenzone, Zinc Oxide, And Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>16110-035-12</NDCCode><ProprietaryName>Cordran</ProprietaryName><NonProprietaryName>Flurandrenolide</NonProprietaryName></NDC><NDC><NDCCode>16110-035-60</NDCCode><ProprietaryName>Cordran</ProprietaryName><NonProprietaryName>Flurandrenolide</NonProprietaryName></NDC><NDC><NDCCode>21695-857-01</NDCCode><ProprietaryName>Necon</ProprietaryName><NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>24909-035-44</NDCCode><ProprietaryName>Terrasil Bed Sore And Pressure Sore Relief</ProprietaryName><NonProprietaryName>Allantoin</NonProprietaryName></NDC><NDC><NDCCode>24909-035-45</NDCCode><ProprietaryName>Terrasil Bed Sore And Pressure Sore Relief</ProprietaryName><NonProprietaryName>Allantoin</NonProprietaryName></NDC><NDC><NDCCode>24909-035-85</NDCCode><ProprietaryName>Terrasil Bed Sore And Pressure Sore Relief</ProprietaryName><NonProprietaryName>Allantoin</NonProprietaryName></NDC><NDC><NDCCode>31722-035-23</NDCCode><ProprietaryName>Aminocaproic Acid</ProprietaryName><NonProprietaryName>Aminocaproic Acid</NonProprietaryName></NDC><NDC><NDCCode>33342-035-06</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33342-035-10</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33342-035-12</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

  • Use the domain parameter to specify required data domain.
  • Use the operation parameter to specify “format_check” operation.
  • Use the q (query) parameter to specify your query.
  • Use the token (API key) query parameter to identify your application.

Optional parameter:

  • Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

  • Use the domain parameter to specify required data domain.
  • Use the operation parameter to specify “format_check” operation.
  • Use the q (query) parameter to specify your query.
  • Use the token (API key) query parameter to identify your application.
  • Use the tin (tin number) parameter to specify your query about tin number.
  • Use the tinname (tin name) parameter to specify your query about tin name.
  • Use the zipcode (zip code) parameter to specify your query about zip code.
  • Use the radius (radius) parameter to specify your query about radius.
  • Use the fromdate (fromdate) parameter to specify your query about from date.
  • Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

  • check_status — this method allows to get current code status.
  • getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
  • getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
  • search — allows retrieval of set of items based on the free-form lookup query.
  • search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

  • validate — allows to determine whether provider's information is valid based on data in the CMS database.
  • paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
  • search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
  • zipradius — allows to get npis by zipcode & radius.
  • npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) based on the free-form lookup query.
    • search_and_keywords - returns not only free-form lookup results but also keywords relevant to the original query.
    • getcode - this method allows retrieval of full infrormation regarding one item based on the provided key.
    • getcodes - this method allows retrieval of full infrormation regarding number of items based on the provided keys.
  • NPI-specific operations:
    • validate — allows to determine whether provider's information is valid based on data in the CMS database.
    • paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
    • search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
    • zipradius — allows to get npis by zipcode & radius.
    • npideactivated — allows to get deactivated npis between two dates.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
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}

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Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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