RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (34 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "49281-726-10",
      "PackageDescription": "10 SYRINGE in 1 CARTON (49281-726-10)  / .5 mL in 1 SYRINGE (49281-726-88) ",
      "NDC11Code": "49281-0726-10",
      "ProductNDC": "49281-726",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flublok Trivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260702",
      "EndMarketingDate": "20270630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125285",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/MISSOURI/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PENNSYLVANIA/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN",
      "StrengthNumber": "45; 45; 45",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260702",
      "EndMarketingDatePackage": "20270630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.",
      "Description": "Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. For the 2026-2027 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/Missouri/11/2025 (H1N1), A/Darwin/1415/2025 (H3N2) and B/Pennsylvania/14/2025. These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex."
    },
    {
      "NDCCode": "16729-726-03",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (16729-726-03)  / 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "16729-0726-03",
      "ProductNDC": "16729-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sugammadex",
      "NonProprietaryName": "Sugammadex",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260804",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214306",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "SUGAMMADEX SODIUM",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "gamma-Cyclodextrins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260804",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION ®(sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-Octakis-S-(2-carboxyethyl)-6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-octathio- γ-cyclodextrin sodium salt(1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)] . This derivative is chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G-Heptakis-S-(2-carboxyethyl)-6 A,6 B,6 C,6 D,6 E,6 F,6 G-heptathio- γ-cyclodextrin sodiumsalt (1:7) with a molecular weight of 2067.90. The structural formula is:."
    },
    {
      "NDCCode": "30142-726-10",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (30142-726-10)  / 8 TABLET in 1 BLISTER PACK",
      "NDC11Code": "30142-0726-10",
      "ProductNDC": "30142-726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stay Awake",
      "NonProprietaryName": "Caffeine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190603",
      "EndMarketingDate": "20270930",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M011",
      "LabelerName": "Kroger Company",
      "SubstanceName": "CAFFEINE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190603",
      "EndMarketingDatePackage": "20270930",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness."
    },
    {
      "NDCCode": "31722-726-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10) ",
      "NDC11Code": "31722-0726-10",
      "ProductNDC": "31722-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Montelukast Sodium",
      "NonProprietaryName": "Montelukast Sodium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202843",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "MONTELUKAST SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140910",
      "SamplePackage": "N",
      "IndicationAndUsage": "Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:  Prophylaxis and chronic treatment of asthma in patients 15 years of   age and older (1.1).  Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).  Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3). Limitations of Use:  Not indicated to treat an acute asthma attack ( 5.2).",
      "Description": "Montelukast sodium USP, the active ingredient in montelukast sodium tablets USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1receptor. Montelukast sodium USP is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]   cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35CINNaO 3S, and its molecular weight is 608.17. The structural formula is:. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "31722-726-31",
      "PackageDescription": "10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31) ",
      "NDC11Code": "31722-0726-31",
      "ProductNDC": "31722-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Montelukast",
      "NonProprietaryName": "Montelukast",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202843",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "MONTELUKAST SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20140910",
      "SamplePackage": "N",
      "IndicationAndUsage": "Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:   Prophylaxis and chronic treatment of asthma in patients 15 years of   age and older  (1.1). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older  (1.2).  Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies  (1.3).",
      "Description": "Montelukast sodium USP, the active ingredient in montelukast sodium tablets, USP is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium USP is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]   cyclopropaneacetic acid, monosodium salt.      The empirical formula is C 35H 35CINNaO 3S, and its molecular weight is 608.17. The structural formula is:. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "31722-726-32",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-726-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31) ",
      "NDC11Code": "31722-0726-32",
      "ProductNDC": "31722-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Montelukast Sodium",
      "NonProprietaryName": "Montelukast Sodium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202843",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "MONTELUKAST SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140910",
      "SamplePackage": "N",
      "IndicationAndUsage": "Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:  Prophylaxis and chronic treatment of asthma in patients 15 years of   age and older (1.1).  Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).  Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3). Limitations of Use:  Not indicated to treat an acute asthma attack ( 5.2).",
      "Description": "Montelukast sodium USP, the active ingredient in montelukast sodium tablets USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1receptor. Montelukast sodium USP is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]   cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35CINNaO 3S, and its molecular weight is 608.17. The structural formula is:. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide."
    },
    {
      "NDCCode": "37808-726-10",
      "PackageDescription": "28.3 g in 1 PACKAGE (37808-726-10) ",
      "NDC11Code": "37808-0726-10",
      "ProductNDC": "37808-726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunscreen",
      "NonProprietaryName": "Octinoxate, Octisalate, Zinc Oxide",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170606",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "HEB",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "75; 50; 100",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170606",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), mdecreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "42291-726-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42291-726-10) ",
      "NDC11Code": "42291-0726-10",
      "ProductNDC": "42291-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Raloxifene Hydrochloride",
      "NonProprietaryName": "Raloxifene Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078193",
      "LabelerName": "AvKARE",
      "SubstanceName": "RALOXIFENE HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20141103",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42543-726-10",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (42543-726-10)",
      "NDC11Code": "42543-0726-10",
      "ProductNDC": "42543-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine",
      "NonProprietaryName": "Fluoxetine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150316",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204597",
      "LabelerName": "Vensun Pharmaceuticals, Inc.",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2017-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150316",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluoxetine is indicated for the treatment of. Fluoxetine and Olanzapine in Combination is indicated for the treatment of. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
      "Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water.Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition, 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
    },
    {
      "NDCCode": "42806-726-10",
      "PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-726-10) ",
      "NDC11Code": "42806-0726-10",
      "ProductNDC": "42806-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Succinate",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213854",
      "LabelerName": "Epic Pharma, LLC",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. ( 1.3) .",
      "Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol Succinate Extended-Release Tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethyl ether and heptane. Inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose, lactose monohydrate (25 mg and 50 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, sugar spheres (composed of corn starch and sucrose), talc, titanium dioxide and triethyl citrate. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "51660-726-30",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (51660-726-30)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "51660-0726-30",
      "ProductNDC": "51660-726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dye-free Childrens Loratadine",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210088",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-01-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240315",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "51660-726-61",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (51660-726-61)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK",
      "NDC11Code": "51660-0726-61",
      "ProductNDC": "51660-726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dye-free Childrens Loratadine",
      "NonProprietaryName": "Loratadine",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210088",
      "LabelerName": "Ohm Laboratories Inc.",
      "SubstanceName": "LORATADINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-01-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241018",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "51811-726-10",
      "PackageDescription": "29.57 mL in 1 BOTTLE, PLASTIC (51811-726-10) ",
      "NDC11Code": "51811-0726-10",
      "ProductNDC": "51811-726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antimicrobial Hand Sanitizer Gel",
      "NonProprietaryName": "Alcohol Gel",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100913",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Hanover Pen Corp dba HPC Global",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "20.699",
      "StrengthUnit": "mL/29.57mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20100913",
      "SamplePackage": "N",
      "IndicationAndUsage": "For handwashing to decrease bacteria on skin. Recommended for repeated use."
    },
    {
      "NDCCode": "55910-726-10",
      "PackageDescription": "28.3 g in 1 PACKAGE (55910-726-10) ",
      "NDC11Code": "55910-0726-10",
      "ProductNDC": "55910-726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunscreen",
      "NonProprietaryName": "Octinoxate, Octisalate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "OLD EAST MAIN CO.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE",
      "StrengthNumber": "562; 250; 1000; 1000",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20191001",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "63739-726-10",
      "PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-726-10)  > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "63739-0726-10",
      "ProductNDC": "63739-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Morphine Sulfate",
      "NonProprietaryName": "Morphine Sulfate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150709",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076720",
      "LabelerName": "McKesson Corporation",
      "SubstanceName": "MORPHINE SULFATE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-05-29",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "70847-726-03",
      "PackageDescription": "1 BAG in 1 CAN (70847-726-03)  > 10 kg in 1 BAG",
      "NDC11Code": "70847-0726-03",
      "ProductNDC": "70847-726",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Benzylpenicillin Procaine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20160801",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "ADL Biopharma SL.",
      "SubstanceName": "PENICILLIN G PROCAINE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "01-AUG-16"
    },
    {
      "NDCCode": "71919-726-10",
      "PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-726-10) ",
      "NDC11Code": "71919-0726-10",
      "ProductNDC": "71919-726",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zincum Iodatum",
      "NonProprietaryName": "Zinc Iodide",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110517",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "ZINC IODIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110517",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-013-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-013-10)  > .5 mL in 1 VIAL, SINGLE-DOSE (49281-013-58)",
      "NDC11Code": "49281-0013-10",
      "ProductNDC": "49281-013",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130628",
      "EndMarketingDate": "20140630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "49281-013-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-013-50)  > .5 mL in 1 SYRINGE, GLASS (49281-013-88)",
      "NDC11Code": "49281-0013-50",
      "ProductNDC": "49281-013",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130628",
      "EndMarketingDate": "20140630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "49281-014-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-014-50)  > .5 mL in 1 SYRINGE, GLASS (49281-014-88)",
      "NDC11Code": "49281-0014-50",
      "ProductNDC": "49281-014",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20140627",
      "EndMarketingDate": "20150630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-03"
    },
    {
      "NDCCode": "49281-016-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-016-50)  / .5 mL in 1 SYRINGE, GLASS (49281-016-88) ",
      "NDC11Code": "49281-0016-50",
      "ProductNDC": "49281-016",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Hd Tiv Sh 2026",
      "NonProprietaryName": "Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260220",
      "EndMarketingDate": "20261231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260220",
      "EndMarketingDatePackage": "20261231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Southern Hemisphere process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose Southern Hemisphere is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Southern Hemisphere. The Fluzone High-Dose Southern Hemisphere prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-026-50",
      "PackageDescription": "10 SYRINGE in 1 CARTON (49281-026-50)  / .5 mL in 1 SYRINGE (49281-026-88) ",
      "NDC11Code": "49281-0026-50",
      "ProductNDC": "49281-026",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Nuvaxovid 2026-27",
      "NonProprietaryName": "Nvx-cov2928",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260827",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125817",
      "LabelerName": "Sanofi Vaccines US Inc.",
      "SubstanceName": "NVX-COV2928",
      "StrengthNumber": "5",
      "StrengthUnit": "ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260827",
      "SamplePackage": "N",
      "IndicationAndUsage": "NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NUVAXOVID is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
      "Description": "NUVAXOVID (COVID-19 Vaccine, Adjuvanted) is a colorless to slightly yellow, clear to mildly opalescent sterile suspension for intramuscular use that is free from visible particles. Each 0.5 mL dose of NUVAXOVID (2026-2027 Formula) contains 5 mcg of recombinant spike glycoprotein (rS) of the SARS-CoV-2 JN.1-descendent variant XFG and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina. The rS protein is produced by recombinant DNA technology using a baculovirus expression system in the Sf9 insect cell line that is derived from the Spodoptera frugiperda species. Each 0.5 mL dose of NUVAXOVID also contains the following ingredients: cholesterol (30.5 mcg), phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg), polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of NUVAXOVID may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (< 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (< 0.92 mcg), pluronic F-68 (< 2.19 mcg), Triton X-100 (< 0.025 mcg), Tergitol (NP9) (< 0.05 mcg), and DL-α-tocopherol (≤ 0.05 mcg). NUVAXOVID does not contain a preservative. The syringe tip cap and plunger stopper are not made with natural rubber latex."
    },
    {
      "NDCCode": "49281-113-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-113-25)  > .25 mL in 1 SYRINGE, GLASS (49281-113-00)",
      "NDC11Code": "49281-0113-25",
      "ProductNDC": "49281-113",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130628",
      "EndMarketingDate": "20140630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "49281-116-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-116-25)  > .25 mL in 1 SYRINGE, GLASS (49281-116-00)",
      "NDC11Code": "49281-0116-25",
      "ProductNDC": "49281-116",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20160324",
      "EndMarketingDate": "20161231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-01-05"
    },
    {
      "NDCCode": "49281-120-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-120-65)  / .7 mL in 1 SYRINGE, GLASS (49281-120-88) ",
      "NDC11Code": "49281-0120-65",
      "ProductNDC": "49281-120",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20200702",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200702",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-121-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-121-65)  / .7 mL in 1 SYRINGE, GLASS (49281-121-88) ",
      "NDC11Code": "49281-0121-65",
      "ProductNDC": "49281-121",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20210702",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210702",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-122-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-122-65)  / .7 mL in 1 SYRINGE, GLASS (49281-122-88) ",
      "NDC11Code": "49281-0122-65",
      "ProductNDC": "49281-122",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
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      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20220701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220701",
      "SamplePackage": "N"
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    {
      "NDCCode": "49281-123-65",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-123-65)  / .7 mL in 1 SYRINGE, GLASS (49281-123-88) ",
      "NDC11Code": "49281-0123-65",
      "ProductNDC": "49281-123",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230630",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
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      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Quadrivalent for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus.\" The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Fluzone High-Dose Quadrivalent suspension for injection is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Quadrivalent. The Fluzone High-Dose Quadrivalent prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "49281-181-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-181-25)  > .25 mL in 1 SYRINGE, GLASS (49281-181-00) ",
      "NDC11Code": "49281-0181-25",
      "ProductNDC": "49281-181",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190930",
      "EndMarketingDate": "20201231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190930",
      "EndMarketingDatePackage": "20201231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-182-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-182-25)  > .25 mL in 1 SYRINGE, GLASS (49281-182-00) ",
      "NDC11Code": "49281-0182-25",
      "ProductNDC": "49281-182",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20210204",
      "EndMarketingDate": "20211231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210204",
      "EndMarketingDatePackage": "20211231",
      "SamplePackage": "N"
    }
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}
                    

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<NDCList>
  <NDC>
    <NDCCode>49281-726-10</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (49281-726-10)  / .5 mL in 1 SYRINGE (49281-726-88) </PackageDescription>
    <NDC11Code>49281-0726-10</NDC11Code>
    <ProductNDC>49281-726</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Flublok Trivalent Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260702</StartMarketingDate>
    <EndMarketingDate>20270630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125285</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/MISSOURI/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/DARWIN/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PENNSYLVANIA/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN</SubstanceName>
    <StrengthNumber>45; 45; 45</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20260702</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in individuals 9 years of age and older.</IndicationAndUsage>
    <Description>Flublok [Influenza Vaccine] is a sterile, clear, colorless injection containing recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular use. It contains purified HA proteins produced in a continuous insect cell line (expresSF+®) that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda (which is related to moths, caterpillars and butterflies), and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose syringes. For the 2026-2027 influenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 influenza virus strains: A/Missouri/11/2025 (H1N1), A/Darwin/1415/2025 (H3N2) and B/Pennsylvania/14/2025. These three influenza virus strains are recommended by FDA for the 2026-2027 influenza season. A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.2 mg), dibasic sodium phosphate (0.5 mg), and polysorbate 20 (Tween®20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain residual amounts of baculovirus and Spodoptera frugiperda cell proteins (≤ 14.3 mcg), baculovirus and cellular DNA (≤ 10 ng), and Triton X-100 (≤ 100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives. The single-dose, prefilled syringes contain no natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-726-03</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (16729-726-03)  / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>16729-0726-03</NDC11Code>
    <ProductNDC>16729-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214306</ApplicationNumber>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260804</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC’s BRIDION ®(sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-Octakis-S-(2-carboxyethyl)-6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-octathio- γ-cyclodextrin sodium salt(1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)] . This derivative is chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G-Heptakis-S-(2-carboxyethyl)-6 A,6 B,6 C,6 D,6 E,6 F,6 G-heptathio- γ-cyclodextrin sodiumsalt (1:7) with a molecular weight of 2067.90. The structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>30142-726-10</NDCCode>
    <PackageDescription>5 BLISTER PACK in 1 CARTON (30142-726-10)  / 8 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>30142-0726-10</NDC11Code>
    <ProductNDC>30142-726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stay Awake</ProprietaryName>
    <NonProprietaryName>Caffeine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190603</StartMarketingDate>
    <EndMarketingDate>20270930</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M011</ApplicationNumber>
    <LabelerName>Kroger Company</LabelerName>
    <SubstanceName>CAFFEINE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190603</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31722-726-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10) </PackageDescription>
    <NDC11Code>31722-0726-10</NDC11Code>
    <ProductNDC>31722-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202843</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:  Prophylaxis and chronic treatment of asthma in patients 15 years of   age and older (1.1).  Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).  Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3). Limitations of Use:  Not indicated to treat an acute asthma attack ( 5.2).</IndicationAndUsage>
    <Description>Montelukast sodium USP, the active ingredient in montelukast sodium tablets USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1receptor. Montelukast sodium USP is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]   cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35CINNaO 3S, and its molecular weight is 608.17. The structural formula is:. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-726-31</NDCCode>
    <PackageDescription>10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31) </PackageDescription>
    <NDC11Code>31722-0726-31</NDC11Code>
    <ProductNDC>31722-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast</ProprietaryName>
    <NonProprietaryName>Montelukast</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202843</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:   Prophylaxis and chronic treatment of asthma in patients 15 years of   age and older  (1.1). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older  (1.2).  Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies  (1.3).</IndicationAndUsage>
    <Description>Montelukast sodium USP, the active ingredient in montelukast sodium tablets, USP is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium USP is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]   cyclopropaneacetic acid, monosodium salt.      The empirical formula is C 35H 35CINNaO 3S, and its molecular weight is 608.17. The structural formula is:. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-726-32</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (31722-726-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31) </PackageDescription>
    <NDC11Code>31722-0726-32</NDC11Code>
    <ProductNDC>31722-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Montelukast Sodium</ProprietaryName>
    <NonProprietaryName>Montelukast Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202843</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MONTELUKAST SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:  Prophylaxis and chronic treatment of asthma in patients 15 years of   age and older (1.1).  Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).  Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3). Limitations of Use:  Not indicated to treat an acute asthma attack ( 5.2).</IndicationAndUsage>
    <Description>Montelukast sodium USP, the active ingredient in montelukast sodium tablets USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1receptor. Montelukast sodium USP is described chemically as [ R-( E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]   cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35CINNaO 3S, and its molecular weight is 608.17. The structural formula is:. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>37808-726-10</NDCCode>
    <PackageDescription>28.3 g in 1 PACKAGE (37808-726-10) </PackageDescription>
    <NDC11Code>37808-0726-10</NDC11Code>
    <ProductNDC>37808-726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunscreen</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170606</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>HEB</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>75; 50; 100</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170606</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), mdecreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>42291-726-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42291-726-10) </PackageDescription>
    <NDC11Code>42291-0726-10</NDC11Code>
    <ProductNDC>42291-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Raloxifene Hydrochloride</ProprietaryName>
    <NonProprietaryName>Raloxifene Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078193</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>RALOXIFENE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42543-726-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (42543-726-10)</PackageDescription>
    <NDC11Code>42543-0726-10</NDC11Code>
    <ProductNDC>42543-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204597</ApplicationNumber>
    <LabelerName>Vensun Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2017-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine is indicated for the treatment of. Fluoxetine and Olanzapine in Combination is indicated for the treatment of. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water.Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&amp;C Blue #1, FD&amp;C Red #3, and titanium dioxide. In addition, 20 mg capsules also contains D&amp;C Yellow #10 and 10 mg capsules also contains FD&amp;C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-726-10</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-726-10) </PackageDescription>
    <NDC11Code>42806-0726-10</NDC11Code>
    <ProductNDC>42806-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213854</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. ( 1.3) .</IndicationAndUsage>
    <Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol Succinate Extended-Release Tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethyl ether and heptane. Inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose, lactose monohydrate (25 mg and 50 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, sugar spheres (composed of corn starch and sucrose), talc, titanium dioxide and triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>51660-726-30</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (51660-726-30)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51660-0726-30</NDC11Code>
    <ProductNDC>51660-726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dye-free Childrens Loratadine</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210088</ApplicationNumber>
    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51660-726-61</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (51660-726-61)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>51660-0726-61</NDC11Code>
    <ProductNDC>51660-726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dye-free Childrens Loratadine</ProprietaryName>
    <NonProprietaryName>Loratadine</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210088</ApplicationNumber>
    <LabelerName>Ohm Laboratories Inc.</LabelerName>
    <SubstanceName>LORATADINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241018</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51811-726-10</NDCCode>
    <PackageDescription>29.57 mL in 1 BOTTLE, PLASTIC (51811-726-10) </PackageDescription>
    <NDC11Code>51811-0726-10</NDC11Code>
    <ProductNDC>51811-726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antimicrobial Hand Sanitizer Gel</ProprietaryName>
    <NonProprietaryName>Alcohol Gel</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100913</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Hanover Pen Corp dba HPC Global</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>20.699</StrengthNumber>
    <StrengthUnit>mL/29.57mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100913</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For handwashing to decrease bacteria on skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55910-726-10</NDCCode>
    <PackageDescription>28.3 g in 1 PACKAGE (55910-726-10) </PackageDescription>
    <NDC11Code>55910-0726-10</NDC11Code>
    <ProductNDC>55910-726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunscreen</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>OLD EAST MAIN CO.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>562; 250; 1000; 1000</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63739-726-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-726-10)  &gt; 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63739-0726-10</NDC11Code>
    <ProductNDC>63739-726</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150709</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076720</ApplicationNumber>
    <LabelerName>McKesson Corporation</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-05-29</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>70847-726-03</NDCCode>
    <PackageDescription>1 BAG in 1 CAN (70847-726-03)  &gt; 10 kg in 1 BAG</PackageDescription>
    <NDC11Code>70847-0726-03</NDC11Code>
    <ProductNDC>70847-726</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Benzylpenicillin Procaine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20160801</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>ADL Biopharma SL.</LabelerName>
    <SubstanceName>PENICILLIN G PROCAINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-AUG-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>71919-726-10</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-726-10) </PackageDescription>
    <NDC11Code>71919-0726-10</NDC11Code>
    <ProductNDC>71919-726</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zincum Iodatum</ProprietaryName>
    <NonProprietaryName>Zinc Iodide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110517</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>ZINC IODIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-013-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-013-10)  &gt; .5 mL in 1 VIAL, SINGLE-DOSE (49281-013-58)</PackageDescription>
    <NDC11Code>49281-0013-10</NDC11Code>
    <ProductNDC>49281-013</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20130628</StartMarketingDate>
    <EndMarketingDate>20140630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-07-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-013-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-013-50)  &gt; .5 mL in 1 SYRINGE, GLASS (49281-013-88)</PackageDescription>
    <NDC11Code>49281-0013-50</NDC11Code>
    <ProductNDC>49281-013</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20130628</StartMarketingDate>
    <EndMarketingDate>20140630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-07-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-014-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-014-50)  &gt; .5 mL in 1 SYRINGE, GLASS (49281-014-88)</PackageDescription>
    <NDC11Code>49281-0014-50</NDC11Code>
    <ProductNDC>49281-014</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20140627</StartMarketingDate>
    <EndMarketingDate>20150630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-016-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-016-50)  / .5 mL in 1 SYRINGE, GLASS (49281-016-88) </PackageDescription>
    <NDC11Code>49281-0016-50</NDC11Code>
    <ProductNDC>49281-016</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Hd Tiv Sh 2026</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260220</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>60; 60; 60</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20260220</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older.</IndicationAndUsage>
    <Description>Fluzone High-Dose Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Southern Hemisphere process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose Southern Hemisphere is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Southern Hemisphere. The Fluzone High-Dose Southern Hemisphere prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-026-50</NDCCode>
    <PackageDescription>10 SYRINGE in 1 CARTON (49281-026-50)  / .5 mL in 1 SYRINGE (49281-026-88) </PackageDescription>
    <NDC11Code>49281-0026-50</NDC11Code>
    <ProductNDC>49281-026</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Nuvaxovid 2026-27</ProprietaryName>
    <NonProprietaryName>Nvx-cov2928</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20260827</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125817</ApplicationNumber>
    <LabelerName>Sanofi Vaccines US Inc.</LabelerName>
    <SubstanceName>NVX-COV2928</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NUVAXOVID is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). NUVAXOVID is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
    <Description>NUVAXOVID (COVID-19 Vaccine, Adjuvanted) is a colorless to slightly yellow, clear to mildly opalescent sterile suspension for intramuscular use that is free from visible particles. Each 0.5 mL dose of NUVAXOVID (2026-2027 Formula) contains 5 mcg of recombinant spike glycoprotein (rS) of the SARS-CoV-2 JN.1-descendent variant XFG and 50 mcg Matrix-M adjuvant. The Matrix-M adjuvant is composed of Fraction-A (42.5 mcg) and Fraction-C (7.5 mcg) of saponin extracts from the soapbark tree, Quillaja saponaria Molina. The rS protein is produced by recombinant DNA technology using a baculovirus expression system in the Sf9 insect cell line that is derived from the Spodoptera frugiperda species. Each 0.5 mL dose of NUVAXOVID also contains the following ingredients: cholesterol (30.5 mcg), phosphatidylcholine (23 mcg), potassium dihydrogen phosphate (3.85 mcg), potassium chloride (2.25 mcg), disodium hydrogen phosphate dihydrate (14.7 mcg), disodium hydrogen phosphate heptahydrate (2.465 mg), sodium dihydrogen phosphate monohydrate (0.445 mg), sodium chloride (8.766 mg), polysorbate 80 (0.050 mg), and Water for Injection. The pH is adjusted with sodium hydroxide or hydrochloric acid. Each 0.5 mL dose of NUVAXOVID may also contain residual amounts of baculovirus and Sf9 cell proteins (≤ 0.96 mcg), baculovirus and cellular DNA (≤ 0.00016 mcg), lentil lectin (&lt; 0.025 mcg), methyl-α-D-mannopyranoside (2 mcg), simethicone (&lt; 0.92 mcg), pluronic F-68 (&lt; 2.19 mcg), Triton X-100 (&lt; 0.025 mcg), Tergitol (NP9) (&lt; 0.05 mcg), and DL-α-tocopherol (≤ 0.05 mcg). NUVAXOVID does not contain a preservative. The syringe tip cap and plunger stopper are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-113-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-113-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-113-00)</PackageDescription>
    <NDC11Code>49281-0113-25</NDC11Code>
    <ProductNDC>49281-113</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20130628</StartMarketingDate>
    <EndMarketingDate>20140630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>7.5; 7.5; 7.5</StrengthNumber>
    <StrengthUnit>ug/.25mL; ug/.25mL; ug/.25mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-07-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-116-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-116-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-116-00)</PackageDescription>
    <NDC11Code>49281-0116-25</NDC11Code>
    <ProductNDC>49281-116</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20160324</StartMarketingDate>
    <EndMarketingDate>20161231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
    <StrengthUnit>ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-01-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-120-65</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-120-65)  / .7 mL in 1 SYRINGE, GLASS (49281-120-88) </PackageDescription>
    <NDC11Code>49281-0120-65</NDC11Code>
    <ProductNDC>49281-120</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20200702</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>60; 60; 60; 60</StrengthNumber>
    <StrengthUnit>ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-121-65</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-121-65)  / .7 mL in 1 SYRINGE, GLASS (49281-121-88) </PackageDescription>
    <NDC11Code>49281-0121-65</NDC11Code>
    <ProductNDC>49281-121</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20210702</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>60; 60; 60; 60</StrengthNumber>
    <StrengthUnit>ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-122-65</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-122-65)  / .7 mL in 1 SYRINGE, GLASS (49281-122-88) </PackageDescription>
    <NDC11Code>49281-0122-65</NDC11Code>
    <ProductNDC>49281-122</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20220701</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>60; 60; 60; 60</StrengthNumber>
    <StrengthUnit>ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-123-65</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-123-65)  / .7 mL in 1 SYRINGE, GLASS (49281-123-88) </PackageDescription>
    <NDC11Code>49281-0123-65</NDC11Code>
    <ProductNDC>49281-123</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20230630</StartMarketingDate>
    <EndMarketingDate>20240630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>60; 60; 60; 60</StrengthNumber>
    <StrengthUnit>ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230630</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® High-Dose Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.</IndicationAndUsage>
    <Description>Fluzone High-Dose Quadrivalent for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus." The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Fluzone High-Dose Quadrivalent suspension for injection is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Quadrivalent. The Fluzone High-Dose Quadrivalent prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2023-2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-181-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-181-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-181-00) </PackageDescription>
    <NDC11Code>49281-0181-25</NDC11Code>
    <ProductNDC>49281-181</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20190930</StartMarketingDate>
    <EndMarketingDate>20201231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
    <StrengthUnit>ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190930</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-182-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-182-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-182-00) </PackageDescription>
    <NDC11Code>49281-0182-25</NDC11Code>
    <ProductNDC>49281-182</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20210204</StartMarketingDate>
    <EndMarketingDate>20211231</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
    <StrengthUnit>ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210204</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>49281-726-10</NDCCode><ProprietaryName>Flublok Trivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/missouri/11/2025 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/darwin/1415/2025 (h3n2) Recombinant Hemagglutinin Antigen, And Influenza B Virus B/pennsylvania/14/2025 Recombinant Hemagglutinin Antigen</NonProprietaryName></NDC><NDC><NDCCode>16729-726-03</NDCCode><ProprietaryName>Sugammadex</ProprietaryName><NonProprietaryName>Sugammadex</NonProprietaryName></NDC><NDC><NDCCode>30142-726-10</NDCCode><ProprietaryName>Stay Awake</ProprietaryName><NonProprietaryName>Caffeine</NonProprietaryName></NDC><NDC><NDCCode>31722-726-10</NDCCode><ProprietaryName>Montelukast Sodium</ProprietaryName><NonProprietaryName>Montelukast Sodium</NonProprietaryName></NDC><NDC><NDCCode>31722-726-31</NDCCode><ProprietaryName>Montelukast</ProprietaryName><NonProprietaryName>Montelukast</NonProprietaryName></NDC><NDC><NDCCode>31722-726-32</NDCCode><ProprietaryName>Montelukast Sodium</ProprietaryName><NonProprietaryName>Montelukast Sodium</NonProprietaryName></NDC><NDC><NDCCode>37808-726-10</NDCCode><ProprietaryName>Sunscreen</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>42291-726-10</NDCCode><ProprietaryName>Raloxifene Hydrochloride</ProprietaryName><NonProprietaryName>Raloxifene Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42543-726-10</NDCCode><ProprietaryName>Fluoxetine</ProprietaryName><NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42806-726-10</NDCCode><ProprietaryName>Metoprolol Succinate</ProprietaryName><NonProprietaryName>Metoprolol Succinate</NonProprietaryName></NDC><NDC><NDCCode>51660-726-30</NDCCode><ProprietaryName>Dye-free Childrens Loratadine</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>51660-726-61</NDCCode><ProprietaryName>Dye-free Childrens Loratadine</ProprietaryName><NonProprietaryName>Loratadine</NonProprietaryName></NDC><NDC><NDCCode>51811-726-10</NDCCode><ProprietaryName>Antimicrobial Hand Sanitizer Gel</ProprietaryName><NonProprietaryName>Alcohol Gel</NonProprietaryName></NDC><NDC><NDCCode>55910-726-10</NDCCode><ProprietaryName>Sunscreen</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>63739-726-10</NDCCode><ProprietaryName>Morphine Sulfate</ProprietaryName><NonProprietaryName>Morphine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>70847-726-03</NDCCode><NonProprietaryName>Benzylpenicillin Procaine</NonProprietaryName></NDC><NDC><NDCCode>71919-726-10</NDCCode><ProprietaryName>Zincum Iodatum</ProprietaryName><NonProprietaryName>Zinc Iodide</NonProprietaryName></NDC><NDC><NDCCode>49281-013-10</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-013-50</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-014-50</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-016-50</NDCCode><ProprietaryName>Fluzone Hd Tiv Sh 2026</ProprietaryName><NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-026-50</NDCCode><ProprietaryName>Nuvaxovid 2026-27</ProprietaryName><NonProprietaryName>Nvx-cov2928</NonProprietaryName></NDC><NDC><NDCCode>49281-113-25</NDCCode><ProprietaryName>Fluzone</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-116-25</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-120-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-121-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-122-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-123-65</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-181-25</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-182-25</NDCCode><ProprietaryName>Fluzone Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</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.

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();
    }
}
            
        

            
{
  "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.",
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      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "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"
    }
  ]
}

Done. Press any key to exit ...
            
        

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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

                
    {
      "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();
        }
    }
                
            

                
{
  "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",
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}
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