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How to Find 70069-362-10 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "70069-362-10",
      "PackageDescription": "10 VIAL in 1 CARTON (70069-362-10)  / 10 mL in 1 VIAL (70069-362-01) ",
      "NDC11Code": "70069-0362-10",
      "ProductNDC": "70069-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212231",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "80; 16",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190829",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)]. Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria. macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).",
      "Description": "Sulfamethoxazole and trimethoprim injection, a sterile solution for intravenous infusion only, is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial. Each mL contains Sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as preservatives; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3%v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. C14H18N4O3                 M.W. 290.3. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S               M.W. 253.28."
    },
    {
      "NDCCode": "24987-362-10",
      "PackageDescription": "10 VIAL in 1 CARTON (24987-362-10)  > 2 mL in 1 VIAL",
      "NDC11Code": "24987-0362-10",
      "ProductNDC": "24987-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zantac",
      "NonProprietaryName": "Ranitidine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20130315",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019090",
      "LabelerName": "Covis Pharmaceuticals, Inc.",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-08-23"
    },
    {
      "NDCCode": "31722-362-31",
      "PackageDescription": "1 KIT in 1 CARTON (31722-362-31)  *  10 mL in 1 VIAL, SINGLE-DOSE (31722-360-31)  *  10 mL in 1 VIAL, SINGLE-USE (31722-361-31) ",
      "NDC11Code": "31722-0362-31",
      "ProductNDC": "31722-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Melphalan Hydrochloride",
      "NonProprietaryName": "Melphalan Hydrochloride",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240523",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215024",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2024-06-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240523",
      "SamplePackage": "N",
      "IndicationAndUsage": "Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.",
      "Description": "Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as L-phenylalanine, 4-[Bis(2-chloroethyl)amino]-Hydrochloride. The molecular formula is C 13H 18Cl 2N 2O 2. HCl and the molecular weight is 341.65. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa 1of ~2.5. Melphalan Hydrochloride for Injection is supplied as a sterile, nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan Hydrochloride for Injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains trisodium citrate dihydrate 0.2 g, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of  10 mL. Melphalan Hydrochloride for Injection is administered intravenously."
    },
    {
      "NDCCode": "33342-362-10",
      "PackageDescription": "90 TABLET in 1 BOTTLE (33342-362-10) ",
      "NDC11Code": "33342-0362-10",
      "ProductNDC": "33342-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
      "NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190329",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210649",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
      "StrengthNumber": "400; 300; 300",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190329",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "36000-362-05",
      "PackageDescription": "5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (36000-362-05)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE",
      "NDC11Code": "36000-0362-05",
      "ProductNDC": "36000-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenylephrine Hydrochloride",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260406",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217032",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260406",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
      "Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C9H13NO2.HCl with a molecular weight of 203.67 g/mol. Its structural formula is depicted below. Phenylephrine hydrochloride, USP is freely soluble in water and in alcohol. Phenylephrine hydrochloride, USP is white or practically white, odorless powder. Phenylephrine hydrochloride injection USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride, USP 10 mg; sodium chloride, USP 3.5 mg; sodium citrate dihydrate, USP 4 mg; citric acid monohydrate, USP 1 mg; and sodium metabisulfite, NF 2 mg in water for injection, USP. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5."
    },
    {
      "NDCCode": "36800-362-10",
      "PackageDescription": "1 TUBE in 1 CARTON (36800-362-10)  / 96.4 g in 1 TUBE",
      "NDC11Code": "36800-0362-10",
      "ProductNDC": "36800-362",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Intensive Enamel Repair Whitening Tp",
      "NonProprietaryName": "Intensive Enamel Repair Whitening Tp",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250617",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Topco Associates LLC",
      "SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
      "StrengthNumber": "5; .15",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250930",
      "SamplePackage": "N",
      "IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact. aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "42806-362-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (42806-362-10) ",
      "NDC11Code": "42806-0362-10",
      "ProductNDC": "42806-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190830",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065182",
      "LabelerName": "EPIC PHARMA, LLC",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190830",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxycycline hyclate tablets, USP are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture susceptibility information is available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Doxycycline hyclate tablets, USP are available as a 20 mg formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is. with a structural formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water. Each tablet contains the following inactive ingredients: hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. Meet USP Dissolution Test 5."
    },
    {
      "NDCCode": "43063-362-10",
      "PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (43063-362-10) ",
      "NDC11Code": "43063-0362-10",
      "ProductNDC": "43063-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062791",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20100630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "43744-362-10",
      "PackageDescription": "1 g in 1 DRUM (43744-362-10)",
      "NDC11Code": "43744-0362-10",
      "ProductNDC": "43744-362",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Estradiol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120606",
      "EndMarketingDate": "20130624",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "ESTRADIOL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130624"
    },
    {
      "NDCCode": "43744-362-15",
      "PackageDescription": "10 g in 1 DRUM (43744-362-15)",
      "NDC11Code": "43744-0362-15",
      "ProductNDC": "43744-362",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Estradiol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120606",
      "EndMarketingDate": "20130624",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "ESTRADIOL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130624"
    },
    {
      "NDCCode": "47335-361-41",
      "PackageDescription": "1 KIT in 1 CARTON (47335-361-41)  *  10 mL in 1 VIAL, SINGLE-DOSE *  10 mL in 1 VIAL (47335-362-40) ",
      "NDC11Code": "47335-0361-41",
      "ProductNDC": "47335-361",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Decitabine",
      "NonProprietaryName": "Decitabine",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20140124",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205582",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "Status": "Active",
      "LastUpdate": "2020-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.",
      "Description": "Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C8H12N4O4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin­-2(1H)-one and it has the following structural formula. Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). DRUG PRODUCT. White to off white lyophilized powder in 20 mL colorless tubular glass single-dose vial with grey bromo butyl rubber stopper and sealed with baby blue flip top aluminum seal. Each vial contains 50 mg decitabine. DILUENT. Clear colorless solution filled in 10 mL colorless tubular glass vial with grey bromo butyl stopper sealed with transparent flip top aluminum seal. Each vial contains 68 mg monobasic potassium phosphate, 11.6 mg sodium hydroxide and 10 mL water for injection."
    },
    {
      "NDCCode": "49643-362-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-362-10) ",
      "NDC11Code": "49643-0362-10",
      "ProductNDC": "49643-362",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Burrobrush Pollen",
      "NonProprietaryName": "Hymenoclea Salsola",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740312",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102211",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "AMBROSIA SALSOLA POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19740312",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
      "Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
    },
    {
      "NDCCode": "49967-362-03",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49967-362-03)  / 10 mL in 1 BOTTLE",
      "NDC11Code": "49967-0362-03",
      "ProductNDC": "49967-362",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Yves Saint Laurent All Hours Foundation Broad Spectrum Spf 20 Sunscreen",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170601",
      "EndMarketingDate": "20250216",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "L'Oreal USA Products Inc",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170601",
      "EndMarketingDatePackage": "20241230",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "51150-362-03",
      "PackageDescription": "1 BOTTLE in 1 CARTON (51150-362-03)  > 10 mL in 1 BOTTLE",
      "NDC11Code": "51150-0362-03",
      "ProductNDC": "51150-362",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Yves Saint Laurent All Hours Foundation Broad Spectrum Spf 20 Sunscreen",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SICOS ET CIE",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-21"
    },
    {
      "NDCCode": "52817-362-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (52817-362-10) ",
      "NDC11Code": "52817-0362-10",
      "ProductNDC": "52817-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate",
      "NonProprietaryName": "Metoprolol Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200981",
      "LabelerName": "TruPharma LLC",
      "SubstanceName": "METOPROLOL TARTRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181201",
      "SamplePackage": "Y",
      "IndicationAndUsage": "Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See   DOSAGE AND ADMINISTRATION,    CONTRAINDICATIONS, and   WARNINGS).",
      "Description": "Metoprolol tartrate is a selective beta 1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is:. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D & C Red #30 Aluminium Lake."
    },
    {
      "NDCCode": "54575-362-10",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-362-10)",
      "NDC11Code": "54575-0362-10",
      "ProductNDC": "54575-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carrot",
      "NonProprietaryName": "Carrot",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Allergy Laboratories, Inc.",
      "SubstanceName": "CARROT",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
    },
    {
      "NDCCode": "58411-362-60",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (58411-362-60)  > 10 mL in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "58411-0362-60",
      "ProductNDC": "58411-362",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shiseido Uv Lip Color Splash",
      "ProprietaryNameSuffix": "Uluru Red",
      "NonProprietaryName": "Avobenzone, Octinoxate, Octocrylene, And Oxybenzone",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SHISEIDO AMERICAS CORPORATION",
      "SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "238; 466; 285; 190",
      "StrengthUnit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180201",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59262-362-11",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (59262-362-11)  > 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "59262-0362-11",
      "ProductNDC": "59262-362",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kids Irritated Eye Relief",
      "NonProprietaryName": "Belladonna And Euphrasia And Hepar Sulphuris And Thuja",
      "DosageFormName": "LIQUID",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20130702",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Similasan Corporation",
      "SubstanceName": "ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE; PLATYCLADUS ORIENTALIS LEAF",
      "StrengthNumber": "6; 6; 12; 15",
      "StrengthUnit": "[hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "59651-362-10",
      "PackageDescription": "1100 TABLET in 1 BAG (59651-362-10) ",
      "NDC11Code": "59651-0362-10",
      "ProductNDC": "59651-362",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "StartMarketingDate": "20200508",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-02-14",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "08-MAY-20"
    },
    {
      "NDCCode": "59746-362-03",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (59746-362-03)  / 10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "59746-0362-03",
      "ProductNDC": "59746-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Valsartan",
      "NonProprietaryName": "Valsartan",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203536",
      "LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
      "SubstanceName": "VALSARTAN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150105",
      "SamplePackage": "N",
      "IndicationAndUsage": "Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
      "Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water.  Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "65862-362-10",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (65862-362-10)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "65862-0362-10",
      "ProductNDC": "65862-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lamotrigine",
      "NonProprietaryName": "Lamotrigine",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090401",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "LAMOTRIGINE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lamotrigine tablets for oral suspension are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures. , 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
      "Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets for oral suspension, USP are supplied for oral administration. The tablets contain 5 mg (white to off-white) or 25 mg (white to off-white) of lamotrigine USP and the following inactive ingredients: black currant flavor, magnesium carbonate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone (PVPK-30), and sucralose. The black currant flavor contains acetic acid, artificial flavors, benzyl alcohol, caramel color, maltodextrin, and triacetin. The tablets for oral suspension meet Organic Impurities Procedure 2 as published in the current USP monograph for Lamotrigine Tablets for Oral Suspension, USP."
    },
    {
      "NDCCode": "68084-362-01",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (68084-362-01)  > 10 TABLET in 1 BLISTER PACK (68084-362-11)",
      "NDC11Code": "68084-0362-01",
      "ProductNDC": "68084-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090923",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040148",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
      "StrengthNumber": "500; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2014-09-26"
    },
    {
      "NDCCode": "68180-362-13",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (68180-362-13)  > 10 TABLET in 1 BLISTER PACK (68180-362-11) ",
      "NDC11Code": "68180-0362-13",
      "ProductNDC": "68180-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151123",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204019",
      "LabelerName": "Lupin Pharmaceuticals, Inc.",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "54",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20151123",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69168-362-07",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69168-362-07)  > 10 TABLET in 1 BOTTLE",
      "NDC11Code": "69168-0362-07",
      "ProductNDC": "69168-362",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Naproxen Caplets",
      "ProprietaryNameSuffix": "All Day Relief For Pain",
      "NonProprietaryName": "Naproxen Sodium 220 Mg",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141223",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090545",
      "LabelerName": "Allegiant Health",
      "SubstanceName": "NAPROXEN SODIUM",
      "StrengthNumber": "220",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2021-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141223",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ common cold ■ temporarily reduces fever."
    },
    {
      "NDCCode": "69584-362-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (69584-362-10) ",
      "NDC11Code": "69584-0362-10",
      "ProductNDC": "69584-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200925",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087068",
      "LabelerName": "Oxford Pharmaceuticals, LLC",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200925",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS AND USAGEHydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
      "Description": "DESCRIPTIONHydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide1,1-dioxide, and its structural formula is. C7H8ClN3O4S2                                                                                   M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, pregelatinized starch from corn, magnesium stearate, microcrystalline cellulose, and FD&C Yellow #6."
    },
    {
      "NDCCode": "71205-362-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE (71205-362-10) ",
      "NDC11Code": "71205-0362-10",
      "ProductNDC": "71205-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA085162",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201221",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets, USP are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose  maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis),  acute rheumatic carditis. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials  of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory  processes involving the eye and its adnexa  such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C21H26O5    M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 10 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6."
    },
    {
      "NDCCode": "72865-362-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (72865-362-10) ",
      "NDC11Code": "72865-0362-10",
      "ProductNDC": "72865-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbidopa And Levodopa",
      "NonProprietaryName": "Carbidopa And Levodopa",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218939",
      "LabelerName": "XLCare Pharmaceuticals, Inc.",
      "SubstanceName": "CARBIDOPA; LEVODOPA",
      "StrengthNumber": "25; 100",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260119",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
      "Description": "Carbidopa and levodopa tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white to creamy-white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.24. Levodopa, USP an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (2S)-2-Amino-3-(3,4-dihydroxyphenyl) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/100 mg containing 10 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets, USP 25 mg/100 mg containing 25 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets, USP 25 mg/250 mg containing 25 mg of carbidopa USP and 250 mg of levodopa USP. Inactive ingredients are microcrystalline cellulose, pregelatinized starch (maize), crospovidone, hydroxypropyl cellulose and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/250 mg also contain FD&C Blue No.2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow No.10. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "76420-362-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (76420-362-10) ",
      "NDC11Code": "76420-0362-10",
      "ProductNDC": "76420-362",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone Hydrochloride",
      "NonProprietaryName": "Oxycodone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077712",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone hydrochloride is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).  Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 10 mg tablets contain D&C Red #30 aluminum lake, the 15 mg tablets contain D&C Yellow #10 aluminum lake, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 20 mg tablets contain FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, and FD&C Yellow #6 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
    },
    {
      "NDCCode": "70069-005-10",
      "PackageDescription": "25 VIAL in 1 CARTON (70069-005-10)  / 1 mL in 1 VIAL (70069-005-01) ",
      "NDC11Code": "70069-0005-10",
      "ProductNDC": "70069-005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyanocobalamin",
      "NonProprietaryName": "Cyanocobalamin",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
      "StartMarketingDate": "20151211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206503",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "CYANOCOBALAMIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyanocobalamin is indicated for Vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. Addisonian (pernicious) anemia. Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy. Fish tapeworm infestation. Malignancy of pancreas or bowel. Folic acid deficiency. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of Vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin injection is also suitable for the Vitamin B12 absorption test (Schilling test).",
      "Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous use. Each mL contains 1,000 mcg cyanocobalamin; sodium chloride 0.9%; benzyl alcohol 1.5%; Water for Injection q.s.; Hydrochloric acid and/or sodium hydroxide for pH adjustment if necessary (4.5-7.0). Cyanocobalamin appears as dark, red crystals or as an amorphous or crystalline, red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The Vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.34%. The structural formula is represented below."
    },
    {
      "NDCCode": "70069-008-10",
      "PackageDescription": "10 CARTON in 1 CARTON (70069-008-10)  / 1 BOTTLE in 1 CARTON (70069-008-01)  / 5 mL in 1 BOTTLE",
      "NDC11Code": "70069-0008-10",
      "ProductNDC": "70069-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epinastine Hydrochloride",
      "NonProprietaryName": "Epinastine Hydrochloride",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20160914",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090951",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "EPINASTINE HYDROCHLORIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic Agonists [MoA], Adrenergic Receptor Agonist [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20160914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Epinastine HCl Ophthalmic Solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.",
      "Description": "Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinastine HCl is represented by the following structural formula. C16H15N3HCl   Mol. Wt. 285.78. Chemical Name:  3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo [1,5-a]azepine hydrochloride. Each mL contains:  Active: epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: benzalkonium chloride 0.01%; Inactives: edetate disodium; water for injection; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). Epinastine HCl has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"70069-362-10","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"24987-362-10","ProprietaryName":"Zantac","NonProprietaryName":"Ranitidine Hydrochloride"},{"NDCCode":"31722-362-31","ProprietaryName":"Melphalan Hydrochloride","NonProprietaryName":"Melphalan Hydrochloride"},{"NDCCode":"33342-362-10","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"36000-362-05","ProprietaryName":"Phenylephrine Hydrochloride","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"36800-362-10","ProprietaryName":"Intensive Enamel Repair Whitening Tp","NonProprietaryName":"Intensive Enamel Repair Whitening Tp"},{"NDCCode":"42806-362-10","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"43063-362-10","ProprietaryName":"Cephalexin","NonProprietaryName":"Cephalexin"},{"NDCCode":"43744-362-10","NonProprietaryName":"Estradiol"},{"NDCCode":"43744-362-15","NonProprietaryName":"Estradiol"},{"NDCCode":"47335-361-41","ProprietaryName":"Decitabine","NonProprietaryName":"Decitabine"},{"NDCCode":"49643-362-10","ProprietaryName":"Burrobrush Pollen","NonProprietaryName":"Hymenoclea Salsola"},{"NDCCode":"49967-362-03","ProprietaryName":"Yves Saint Laurent All Hours Foundation Broad Spectrum Spf 20 Sunscreen","NonProprietaryName":"Octinoxate"},{"NDCCode":"51150-362-03","ProprietaryName":"Yves Saint Laurent All Hours Foundation Broad Spectrum Spf 20 Sunscreen","NonProprietaryName":"Octinoxate"},{"NDCCode":"52817-362-10","ProprietaryName":"Metoprolol Tartrate","NonProprietaryName":"Metoprolol Tartrate"},{"NDCCode":"54575-362-10","ProprietaryName":"Carrot","NonProprietaryName":"Carrot"},{"NDCCode":"58411-362-60","ProprietaryName":"Shiseido Uv Lip Color Splash","NonProprietaryName":"Avobenzone, Octinoxate, Octocrylene, And Oxybenzone"},{"NDCCode":"59262-362-11","ProprietaryName":"Kids Irritated Eye Relief","NonProprietaryName":"Belladonna And Euphrasia And Hepar Sulphuris And Thuja"},{"NDCCode":"59651-362-10","NonProprietaryName":"Ibuprofen"},{"NDCCode":"59746-362-03","ProprietaryName":"Valsartan","NonProprietaryName":"Valsartan"},{"NDCCode":"65862-362-10","ProprietaryName":"Lamotrigine","NonProprietaryName":"Lamotrigine"},{"NDCCode":"68084-362-01","ProprietaryName":"Hydrocodone Bitartrate And Acetaminophen","NonProprietaryName":"Hydrocodone Bitartrate And Acetaminophen"},{"NDCCode":"68180-362-13","ProprietaryName":"Fenofibrate","NonProprietaryName":"Fenofibrate"},{"NDCCode":"69168-362-07","ProprietaryName":"Naproxen Caplets","NonProprietaryName":"Naproxen Sodium 220 Mg"},{"NDCCode":"69584-362-10","ProprietaryName":"Hydrochlorothiazide","NonProprietaryName":"Hydrochlorothiazide"},{"NDCCode":"71205-362-10","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"72865-362-10","ProprietaryName":"Carbidopa And Levodopa","NonProprietaryName":"Carbidopa And Levodopa"},{"NDCCode":"76420-362-10","ProprietaryName":"Oxycodone Hydrochloride","NonProprietaryName":"Oxycodone Hydrochloride"},{"NDCCode":"70069-005-10","ProprietaryName":"Cyanocobalamin","NonProprietaryName":"Cyanocobalamin"},{"NDCCode":"70069-008-10","ProprietaryName":"Epinastine Hydrochloride","NonProprietaryName":"Epinastine Hydrochloride"}]}
                    
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<NDCList>
  <NDC>
    <NDCCode>70069-362-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (70069-362-10)  / 10 mL in 1 VIAL (70069-362-01) </PackageDescription>
    <NDC11Code>70069-0362-10</NDC11Code>
    <ProductNDC>70069-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190829</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212231</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>80; 16</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190829</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)]. Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria. macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).</IndicationAndUsage>
    <Description>Sulfamethoxazole and trimethoprim injection, a sterile solution for intravenous infusion only, is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial. Each mL contains Sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as preservatives; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3%v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. C14H18N4O3                 M.W. 290.3. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S               M.W. 253.28.</Description>
  </NDC>
  <NDC>
    <NDCCode>24987-362-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (24987-362-10)  &gt; 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>24987-0362-10</NDC11Code>
    <ProductNDC>24987-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zantac</ProprietaryName>
    <NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20130315</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019090</ApplicationNumber>
    <LabelerName>Covis Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-08-23</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>31722-362-31</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (31722-362-31)  *  10 mL in 1 VIAL, SINGLE-DOSE (31722-360-31)  *  10 mL in 1 VIAL, SINGLE-USE (31722-361-31) </PackageDescription>
    <NDC11Code>31722-0362-31</NDC11Code>
    <ProductNDC>31722-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Melphalan Hydrochloride</ProprietaryName>
    <NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215024</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.</IndicationAndUsage>
    <Description>Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as L-phenylalanine, 4-[Bis(2-chloroethyl)amino]-Hydrochloride. The molecular formula is C 13H 18Cl 2N 2O 2. HCl and the molecular weight is 341.65. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa 1of ~2.5. Melphalan Hydrochloride for Injection is supplied as a sterile, nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan Hydrochloride for Injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains trisodium citrate dihydrate 0.2 g, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of  10 mL. Melphalan Hydrochloride for Injection is administered intravenously.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-362-10</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (33342-362-10) </PackageDescription>
    <NDC11Code>33342-0362-10</NDC11Code>
    <ProductNDC>33342-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName>
    <NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210649</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
    <StrengthNumber>400; 300; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>36000-362-05</NDCCode>
    <PackageDescription>5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (36000-362-05)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
    <NDC11Code>36000-0362-05</NDC11Code>
    <ProductNDC>36000-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217032</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260406</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
    <Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C9H13NO2.HCl with a molecular weight of 203.67 g/mol. Its structural formula is depicted below. Phenylephrine hydrochloride, USP is freely soluble in water and in alcohol. Phenylephrine hydrochloride, USP is white or practically white, odorless powder. Phenylephrine hydrochloride injection USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride, USP 10 mg; sodium chloride, USP 3.5 mg; sodium citrate dihydrate, USP 4 mg; citric acid monohydrate, USP 1 mg; and sodium metabisulfite, NF 2 mg in water for injection, USP. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>36800-362-10</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (36800-362-10)  / 96.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>36800-0362-10</NDC11Code>
    <ProductNDC>36800-362</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Intensive Enamel Repair Whitening Tp</ProprietaryName>
    <NonProprietaryName>Intensive Enamel Repair Whitening Tp</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250617</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Topco Associates LLC</LabelerName>
    <SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>5; .15</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42806-362-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (42806-362-10) </PackageDescription>
    <NDC11Code>42806-0362-10</NDC11Code>
    <ProductNDC>42806-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190830</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065182</ApplicationNumber>
    <LabelerName>EPIC PHARMA, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxycycline hyclate tablets, USP are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture susceptibility information is available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Doxycycline hyclate tablets, USP are available as a 20 mg formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is. with a structural formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water. Each tablet contains the following inactive ingredients: hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. Meet USP Dissolution Test 5.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-362-10</NDCCode>
    <PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (43063-362-10) </PackageDescription>
    <NDC11Code>43063-0362-10</NDC11Code>
    <ProductNDC>43063-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100621</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062791</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43744-362-10</NDCCode>
    <PackageDescription>1 g in 1 DRUM (43744-362-10)</PackageDescription>
    <NDC11Code>43744-0362-10</NDC11Code>
    <ProductNDC>43744-362</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120606</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>43744-362-15</NDCCode>
    <PackageDescription>10 g in 1 DRUM (43744-362-15)</PackageDescription>
    <NDC11Code>43744-0362-15</NDC11Code>
    <ProductNDC>43744-362</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120606</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>47335-361-41</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (47335-361-41)  *  10 mL in 1 VIAL, SINGLE-DOSE *  10 mL in 1 VIAL (47335-362-40) </PackageDescription>
    <NDC11Code>47335-0361-41</NDC11Code>
    <ProductNDC>47335-361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Decitabine</ProprietaryName>
    <NonProprietaryName>Decitabine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20140124</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205582</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2020-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.</IndicationAndUsage>
    <Description>Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C8H12N4O4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin­-2(1H)-one and it has the following structural formula. Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). DRUG PRODUCT. White to off white lyophilized powder in 20 mL colorless tubular glass single-dose vial with grey bromo butyl rubber stopper and sealed with baby blue flip top aluminum seal. Each vial contains 50 mg decitabine. DILUENT. Clear colorless solution filled in 10 mL colorless tubular glass vial with grey bromo butyl stopper sealed with transparent flip top aluminum seal. Each vial contains 68 mg monobasic potassium phosphate, 11.6 mg sodium hydroxide and 10 mL water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49643-362-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-362-10) </PackageDescription>
    <NDC11Code>49643-0362-10</NDC11Code>
    <ProductNDC>49643-362</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Burrobrush Pollen</ProprietaryName>
    <NonProprietaryName>Hymenoclea Salsola</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740312</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102211</ApplicationNumber>
    <LabelerName>Allermed Laboratories, Inc.</LabelerName>
    <SubstanceName>AMBROSIA SALSOLA POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19740312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
    <Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
  </NDC>
  <NDC>
    <NDCCode>49967-362-03</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49967-362-03)  / 10 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49967-0362-03</NDC11Code>
    <ProductNDC>49967-362</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Yves Saint Laurent All Hours Foundation Broad Spectrum Spf 20 Sunscreen</ProprietaryName>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170601</StartMarketingDate>
    <EndMarketingDate>20250216</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>L'Oreal USA Products Inc</LabelerName>
    <SubstanceName>OCTINOXATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241230</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51150-362-03</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (51150-362-03)  &gt; 10 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>51150-0362-03</NDC11Code>
    <ProductNDC>51150-362</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Yves Saint Laurent All Hours Foundation Broad Spectrum Spf 20 Sunscreen</ProprietaryName>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SICOS ET CIE</LabelerName>
    <SubstanceName>OCTINOXATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>52817-362-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (52817-362-10) </PackageDescription>
    <NDC11Code>52817-0362-10</NDC11Code>
    <ProductNDC>52817-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Tartrate</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200981</ApplicationNumber>
    <LabelerName>TruPharma LLC</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See   DOSAGE AND ADMINISTRATION,    CONTRAINDICATIONS, and   WARNINGS).</IndicationAndUsage>
    <Description>Metoprolol tartrate is a selective beta 1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is:. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D &amp; C Red #30 Aluminium Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>54575-362-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-362-10)</PackageDescription>
    <NDC11Code>54575-0362-10</NDC11Code>
    <ProductNDC>54575-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carrot</ProprietaryName>
    <NonProprietaryName>Carrot</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>CARROT</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>58411-362-60</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (58411-362-60)  &gt; 10 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>58411-0362-60</NDC11Code>
    <ProductNDC>58411-362</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shiseido Uv Lip Color Splash</ProprietaryName>
    <ProprietaryNameSuffix>Uluru Red</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octinoxate, Octocrylene, And Oxybenzone</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>238; 466; 285; 190</StrengthNumber>
    <StrengthUnit>mg/10mL; mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59262-362-11</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (59262-362-11)  &gt; 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>59262-0362-11</NDC11Code>
    <ProductNDC>59262-362</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kids Irritated Eye Relief</ProprietaryName>
    <NonProprietaryName>Belladonna And Euphrasia And Hepar Sulphuris And Thuja</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20130702</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Similasan Corporation</LabelerName>
    <SubstanceName>ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE; PLATYCLADUS ORIENTALIS LEAF</SubstanceName>
    <StrengthNumber>6; 6; 12; 15</StrengthNumber>
    <StrengthUnit>[hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>59651-362-10</NDCCode>
    <PackageDescription>1100 TABLET in 1 BAG (59651-362-10) </PackageDescription>
    <NDC11Code>59651-0362-10</NDC11Code>
    <ProductNDC>59651-362</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <StartMarketingDate>20200508</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>08-MAY-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>59746-362-03</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (59746-362-03)  / 10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>59746-0362-03</NDC11Code>
    <ProductNDC>59746-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203536</ApplicationNumber>
    <LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
    <Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water.  Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-362-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (65862-362-10)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>65862-0362-10</NDC11Code>
    <ProductNDC>65862-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamotrigine</ProprietaryName>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090401</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamotrigine tablets for oral suspension are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures. , 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
    <Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets for oral suspension, USP are supplied for oral administration. The tablets contain 5 mg (white to off-white) or 25 mg (white to off-white) of lamotrigine USP and the following inactive ingredients: black currant flavor, magnesium carbonate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone (PVPK-30), and sucralose. The black currant flavor contains acetic acid, artificial flavors, benzyl alcohol, caramel color, maltodextrin, and triacetin. The tablets for oral suspension meet Organic Impurities Procedure 2 as published in the current USP monograph for Lamotrigine Tablets for Oral Suspension, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>68084-362-01</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (68084-362-01)  &gt; 10 TABLET in 1 BLISTER PACK (68084-362-11)</PackageDescription>
    <NDC11Code>68084-0362-01</NDC11Code>
    <ProductNDC>68084-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090923</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040148</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
    <StrengthNumber>500; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2014-09-26</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>68180-362-13</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (68180-362-13)  &gt; 10 TABLET in 1 BLISTER PACK (68180-362-11) </PackageDescription>
    <NDC11Code>68180-0362-13</NDC11Code>
    <ProductNDC>68180-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151123</StartMarketingDate>
    <EndMarketingDate>20220531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204019</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>54</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20151123</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69168-362-07</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (69168-362-07)  &gt; 10 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>69168-0362-07</NDC11Code>
    <ProductNDC>69168-362</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naproxen Caplets</ProprietaryName>
    <ProprietaryNameSuffix>All Day Relief For Pain</ProprietaryNameSuffix>
    <NonProprietaryName>Naproxen Sodium 220 Mg</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141223</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090545</ApplicationNumber>
    <LabelerName>Allegiant Health</LabelerName>
    <SubstanceName>NAPROXEN SODIUM</SubstanceName>
    <StrengthNumber>220</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-04-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ common cold ■ temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69584-362-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (69584-362-10) </PackageDescription>
    <NDC11Code>69584-0362-10</NDC11Code>
    <ProductNDC>69584-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200925</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA087068</ApplicationNumber>
    <LabelerName>Oxford Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200925</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS AND USAGEHydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
    <Description>DESCRIPTIONHydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide1,1-dioxide, and its structural formula is. C7H8ClN3O4S2                                                                                   M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, pregelatinized starch from corn, magnesium stearate, microcrystalline cellulose, and FD&amp;C Yellow #6.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-362-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (71205-362-10) </PackageDescription>
    <NDC11Code>71205-0362-10</NDC11Code>
    <ProductNDC>71205-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19900101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA085162</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets, USP are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose  maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis),  acute rheumatic carditis. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials  of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory  processes involving the eye and its adnexa  such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C21H26O5    M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 10 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&amp;C Yellow No. 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>72865-362-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (72865-362-10) </PackageDescription>
    <NDC11Code>72865-0362-10</NDC11Code>
    <ProductNDC>72865-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260119</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218939</ApplicationNumber>
    <LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
    <StrengthNumber>25; 100</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
    <Description>Carbidopa and levodopa tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white to creamy-white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.24. Levodopa, USP an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (2S)-2-Amino-3-(3,4-dihydroxyphenyl) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/100 mg containing 10 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets, USP 25 mg/100 mg containing 25 mg of carbidopa USP and 100 mg of levodopa USP. Carbidopa and levodopa tablets, USP 25 mg/250 mg containing 25 mg of carbidopa USP and 250 mg of levodopa USP. Inactive ingredients are microcrystalline cellulose, pregelatinized starch (maize), crospovidone, hydroxypropyl cellulose and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/250 mg also contain FD&amp;C Blue No.2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&amp;C Yellow No.10. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-362-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (76420-362-10) </PackageDescription>
    <NDC11Code>76420-0362-10</NDC11Code>
    <ProductNDC>76420-362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077712</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxycodone hydrochloride is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).  Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 10 mg tablets contain D&amp;C Red #30 aluminum lake, the 15 mg tablets contain D&amp;C Yellow #10 aluminum lake, the 15 mg and 30 mg tablets contain FD&amp;C Blue #1 aluminum lake, and the 20 mg tablets contain FD&amp;C Blue #2 aluminum lake, FD&amp;C Red #40 aluminum lake, and FD&amp;C Yellow #6 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-005-10</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (70069-005-10)  / 1 mL in 1 VIAL (70069-005-01) </PackageDescription>
    <NDC11Code>70069-0005-10</NDC11Code>
    <ProductNDC>70069-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyanocobalamin</ProprietaryName>
    <NonProprietaryName>Cyanocobalamin</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20151211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206503</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyanocobalamin is indicated for Vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. Addisonian (pernicious) anemia. Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy. Fish tapeworm infestation. Malignancy of pancreas or bowel. Folic acid deficiency. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of Vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin injection is also suitable for the Vitamin B12 absorption test (Schilling test).</IndicationAndUsage>
    <Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous use. Each mL contains 1,000 mcg cyanocobalamin; sodium chloride 0.9%; benzyl alcohol 1.5%; Water for Injection q.s.; Hydrochloric acid and/or sodium hydroxide for pH adjustment if necessary (4.5-7.0). Cyanocobalamin appears as dark, red crystals or as an amorphous or crystalline, red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The Vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.34%. The structural formula is represented below.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-008-10</NDCCode>
    <PackageDescription>10 CARTON in 1 CARTON (70069-008-10)  / 1 BOTTLE in 1 CARTON (70069-008-01)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>70069-0008-10</NDC11Code>
    <ProductNDC>70069-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epinastine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Epinastine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20160914</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090951</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>EPINASTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic Agonists [MoA], Adrenergic Receptor Agonist [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160914</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Epinastine HCl Ophthalmic Solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.</IndicationAndUsage>
    <Description>Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinastine HCl is represented by the following structural formula. C16H15N3HCl   Mol. Wt. 285.78. Chemical Name:  3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo [1,5-a]azepine hydrochloride. Each mL contains:  Active: epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: benzalkonium chloride 0.01%; Inactives: edetate disodium; water for injection; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). Epinastine HCl has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>70069-362-10</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>24987-362-10</NDCCode><ProprietaryName>Zantac</ProprietaryName><NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>31722-362-31</NDCCode><ProprietaryName>Melphalan Hydrochloride</ProprietaryName><NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33342-362-10</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>36000-362-05</NDCCode><ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>36800-362-10</NDCCode><ProprietaryName>Intensive Enamel Repair Whitening Tp</ProprietaryName><NonProprietaryName>Intensive Enamel Repair Whitening Tp</NonProprietaryName></NDC><NDC><NDCCode>42806-362-10</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>43063-362-10</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC><NDC><NDCCode>43744-362-10</NDCCode><NonProprietaryName>Estradiol</NonProprietaryName></NDC><NDC><NDCCode>43744-362-15</NDCCode><NonProprietaryName>Estradiol</NonProprietaryName></NDC><NDC><NDCCode>47335-361-41</NDCCode><ProprietaryName>Decitabine</ProprietaryName><NonProprietaryName>Decitabine</NonProprietaryName></NDC><NDC><NDCCode>49643-362-10</NDCCode><ProprietaryName>Burrobrush Pollen</ProprietaryName><NonProprietaryName>Hymenoclea Salsola</NonProprietaryName></NDC><NDC><NDCCode>49967-362-03</NDCCode><ProprietaryName>Yves Saint Laurent All Hours Foundation Broad Spectrum Spf 20 Sunscreen</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>51150-362-03</NDCCode><ProprietaryName>Yves Saint Laurent All Hours Foundation Broad Spectrum Spf 20 Sunscreen</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>52817-362-10</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>54575-362-10</NDCCode><ProprietaryName>Carrot</ProprietaryName><NonProprietaryName>Carrot</NonProprietaryName></NDC><NDC><NDCCode>58411-362-60</NDCCode><ProprietaryName>Shiseido Uv Lip Color Splash</ProprietaryName><NonProprietaryName>Avobenzone, Octinoxate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>59262-362-11</NDCCode><ProprietaryName>Kids Irritated Eye Relief</ProprietaryName><NonProprietaryName>Belladonna And Euphrasia And Hepar Sulphuris And Thuja</NonProprietaryName></NDC><NDC><NDCCode>59651-362-10</NDCCode><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>59746-362-03</NDCCode><ProprietaryName>Valsartan</ProprietaryName><NonProprietaryName>Valsartan</NonProprietaryName></NDC><NDC><NDCCode>65862-362-10</NDCCode><ProprietaryName>Lamotrigine</ProprietaryName><NonProprietaryName>Lamotrigine</NonProprietaryName></NDC><NDC><NDCCode>68084-362-01</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>68180-362-13</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>69168-362-07</NDCCode><ProprietaryName>Naproxen Caplets</ProprietaryName><NonProprietaryName>Naproxen Sodium 220 Mg</NonProprietaryName></NDC><NDC><NDCCode>69584-362-10</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>71205-362-10</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>72865-362-10</NDCCode><ProprietaryName>Carbidopa And Levodopa</ProprietaryName><NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName></NDC><NDC><NDCCode>76420-362-10</NDCCode><ProprietaryName>Oxycodone Hydrochloride</ProprietaryName><NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70069-005-10</NDCCode><ProprietaryName>Cyanocobalamin</ProprietaryName><NonProprietaryName>Cyanocobalamin</NonProprietaryName></NDC><NDC><NDCCode>70069-008-10</NDCCode><ProprietaryName>Epinastine Hydrochloride</ProprietaryName><NonProprietaryName>Epinastine Hydrochloride</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",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
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      "OtherIdentifierState3": "WA",
      "OtherIdentifierIssuer3": "MEDICARE PTAN",
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      "OtherIdentifierIssuer2": "RAILROAD MEDICARE"
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      "LastUpdateDate": "07/28/2017",
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      "TaxonomyCode2": "122300000X",
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    },
    {
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      "LicenseNumber1": "ME 79876",
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    },
    {
      "NPI": "1326095100",
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    {
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      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
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    },
    {
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      "MailingAddressTelephoneNumber": "216-778-7800",
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      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
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    },
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      "LastName": "AMPEY",
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      "MiddleName": "L",
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      "LastUpdateDate": "12/30/2010",
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      "Gender": "Female",
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      "Taxonomy1": "Professional",
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    },
    {
      "NPI": "1801839667",
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      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
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      "MailingAddressPostalCode": "08055-6283",
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      "MailingAddressTelephoneNumber": "609-677-1046",
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      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
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      "PracticeLocationAddressPostalCode": "08015-1705",
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      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
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      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
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      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
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      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
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    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
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      "SecondLineMailingAddress": "PO BOX 865",
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      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
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      "Taxonomy1": "Family Medicine",
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    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
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      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
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      "MailingAddressTelephoneNumber": "856-342-3150",
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      "PracticeLocationAddressPostalCode": "08103-1461",
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      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

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Full Text Search Fundamentals

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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