RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (34 ms elapsed)

{
  "NDC": [
    {
      "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"
    },
    {
      "NDCCode": "11673-182-52",
      "PackageDescription": "25 TABLET, COATED in 1 BLISTER PACK (11673-182-52) ",
      "NDC11Code": "11673-0182-52",
      "ProductNDC": "11673-182",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bisacodyl",
      "NonProprietaryName": "Biscodyl",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200204",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "TARGET CORPORATION",
      "SubstanceName": "BISACODYL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2024-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200204",
      "SamplePackage": "N",
      "IndicationAndUsage": "for relief of occasional constipation and irregularity. this product generally produces bowel movement in 6-12 hours."
    },
    {
      "NDCCode": "21695-182-25",
      "PackageDescription": "25 g in 1 TUBE (21695-182-25)",
      "NDC11Code": "21695-0182-25",
      "ProductNDC": "21695-182",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Thermazene",
      "ProprietaryNameSuffix": "Silver Sulfadiazine",
      "NonProprietaryName": "Silver Sulfadiazine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19851223",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018810",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "SILVER SULFADIAZINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Thermazene® (Silver Sulfadiazine) Cream, 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.",
      "Description": "Thermazene (silver sulfadiazine Cream, 1% is a soft, water dispersible cream containing silver sulfadiazine in micronized form for topical application.  Each gram of Thermazene contains 10mg of micronized silver sulfadiazine.  Thermazene contains 1% w/w silver sulfadiazine.  The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol NF, white petrolatum USP, polyoxyl 40 stearate NF, propylene glycol USP, isopropyl myristate NF, and sorbitan monooleate NF with 0.3% methylparaben NF as a preservative."
    },
    {
      "NDCCode": "25021-182-66",
      "PackageDescription": "25 VIAL in 1 CARTON (25021-182-66)  > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "25021-0182-66",
      "ProductNDC": "25021-182",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefuroxime Sodium",
      "NonProprietaryName": "Cefuroxime Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20160901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064125",
      "LabelerName": "Sagent Pharmaceuticals",
      "SubstanceName": "CEFUROXIME SODIUM",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20160901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: : 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp., 3 Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp., 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non- penicillinase-producing strains). .",
      "Description": "Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5."
    },
    {
      "NDCCode": "51655-182-25",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (51655-182-25)",
      "NDC11Code": "51655-0182-25",
      "ProductNDC": "51655-182",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hcl",
      "NonProprietaryName": "Tramadol Hcl",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171003",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090404",
      "LabelerName": "Northwind Pharmaceuticals",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Tramadol Hydrochloride Tablets, USP are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS), reserve tramadol for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated, or are not expected to be tolerated. Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee7179b7-6a08-4eeb-a787-5d697b02c4a2.",
      "Description": "Tramadol hydrochloride tablets, USP are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Please view structure at permalink below. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. The molecular weight of tramadol hydrochloride is 299.84. Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee7179b7-6a08-4eeb-a787-5d697b02c4a2."
    },
    {
      "NDCCode": "55570-182-10",
      "PackageDescription": "25 kg in 1 BOX (55570-182-10) ",
      "NDC11Code": "55570-0182-10",
      "ProductNDC": "55570-182",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Chromium Picolinate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20250310",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Jost Chemical Co.",
      "SubstanceName": "CHROMIUM PICOLINATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "24-MAR-25"
    },
    {
      "NDCCode": "59779-182-25",
      "PackageDescription": "1 BOTTLE in 1 BOX (59779-182-25)  > 250 TABLET in 1 BOTTLE",
      "NDC11Code": "59779-0182-25",
      "ProductNDC": "59779-182",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Senna Laxative",
      "ProprietaryNameSuffix": "Natural Vegetable Laxative",
      "NonProprietaryName": "Sennosides",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100729",
      "EndMarketingDate": "20200729",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "SENNOSIDES",
      "StrengthNumber": "8.6",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100729",
      "EndMarketingDatePackage": "20200729",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73377-182-03",
      "PackageDescription": "25 g in 1 JAR (73377-182-03) ",
      "NDC11Code": "73377-0182-03",
      "ProductNDC": "73377-182",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Dorzolamide Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220829",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AX Pharmaceutical Corp",
      "SubstanceName": "DORZOLAMIDE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-07-17",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "07-DEC-23"
    },
    {
      "NDCCode": "76150-182-32",
      "PackageDescription": "4.25 g in 1 TUBE (76150-182-32)",
      "NDC11Code": "76150-0182-32",
      "ProductNDC": "76150-182",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mineral Lip Tan Line",
      "ProprietaryNameSuffix": "Spf 30 Broad Spectrum",
      "NonProprietaryName": "Sunscreen",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Bell International Laboratories, Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "2.8; 1.4",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "85766-182-25",
      "PackageDescription": "250 PACKET in 1 BOX (85766-182-25)  / 1 TABLET, FILM COATED in 1 PACKET",
      "NDC11Code": "85766-0182-25",
      "ProductNDC": "85766-182",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medi-first Plus Sinus Decongestant",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260307",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Sportpharm LLC",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260307",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. Temporarily relieves. ■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies. ■ sinus congestion and pressure."
    },
    {
      "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": "49281-181-25",
      "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": "49281-513-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-513-25)  > .25 mL in 1 SYRINGE, GLASS (49281-513-00)",
      "NDC11Code": "49281-0513-25",
      "ProductNDC": "49281-513",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent",
      "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), Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130610",
      "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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "49281-514-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-514-25)  > .25 mL in 1 SYRINGE, GLASS (49281-514-00)",
      "NDC11Code": "49281-0514-25",
      "ProductNDC": "49281-514",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent",
      "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), Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20150219",
      "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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-03"
    },
    {
      "NDCCode": "49281-515-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-515-25)  > .25 mL in 1 SYRINGE, GLASS (49281-515-00)",
      "NDC11Code": "49281-0515-25",
      "ProductNDC": "49281-515",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/switzerland/9715293/2013 Nib-88 (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": "20150626",
      "EndMarketingDate": "20160630",
      "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/SWITZERLAND/9715293/2013 NIB-88 (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": "2016-12-02"
    },
    {
      "NDCCode": "49281-516-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-516-25)  > .25 mL in 1 SYRINGE, GLASS (49281-516-00)",
      "NDC11Code": "49281-0516-25",
      "ProductNDC": "49281-516",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent",
      "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": "20160701",
      "EndMarketingDate": "20170630",
      "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": "2017-07-03"
    },
    {
      "NDCCode": "49281-517-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-517-25)  > .25 mL in 1 SYRINGE, GLASS (49281-517-00)",
      "NDC11Code": "49281-0517-25",
      "ProductNDC": "49281-517",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent",
      "NonProprietaryName": "Influenza A Virus A/michigan/45/2015 X-275 (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": "20170701",
      "EndMarketingDate": "20180630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (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": "2018-07-02",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "49281-518-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-518-25)  > .25 mL in 1 SYRINGE, GLASS (49281-518-00) ",
      "NDC11Code": "49281-0518-25",
      "ProductNDC": "49281-518",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent",
      "NonProprietaryName": "Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190123",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190123",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-519-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-519-25)  / .25 mL in 1 SYRINGE, GLASS (49281-519-00) ",
      "NDC11Code": "49281-0519-25",
      "ProductNDC": "49281-519",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent Northern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190701",
      "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/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone Quadrivalent (Influenza Vaccine) 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 Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone 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 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49281-520-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-520-25)  > .25 mL in 1 SYRINGE, GLASS (49281-520-00) ",
      "NDC11Code": "49281-0520-25",
      "ProductNDC": "49281-520",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent",
      "NonProprietaryName": "Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 (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": "20200702",
      "EndMarketingDate": "20210630",
      "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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200702",
      "EndMarketingDatePackage": "20210630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-521-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-521-25)  > .25 mL in 1 SYRINGE, GLASS (49281-521-00) ",
      "NDC11Code": "49281-0521-25",
      "ProductNDC": "49281-521",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone Quadrivalent",
      "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), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20210702",
      "EndMarketingDate": "20220630",
      "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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210702",
      "EndMarketingDatePackage": "20220630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49281-650-25",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (49281-650-25)  > .25 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "49281-0650-25",
      "ProductNDC": "49281-650",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Influenza A (h1n1) 2009 Monovalent Vaccine",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15",
      "StrengthUnit": "ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "49281-650-70",
      "PackageDescription": "25 SYRINGE, GLASS in 1 CARTON (49281-650-70)  > .25 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "49281-0650-70",
      "ProductNDC": "49281-650",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Influenza A (h1n1) 2009 Monovalent Vaccine",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15",
      "StrengthUnit": "ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "49281-650-90",
      "PackageDescription": "25 SYRINGE, GLASS in 1 CARTON (49281-650-90)  > .5 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "49281-0650-90",
      "ProductNDC": "49281-650",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Influenza A (h1n1) 2009 Monovalent Vaccine",
      "NonProprietaryName": "Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15",
      "StrengthUnit": "ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "76420-517-01",
      "PackageDescription": "1 KIT in 1 CARTON (76420-517-01)  *  .25 mL in 1 SYRINGE, GLASS (49281-516-00)  *  1 APPLICATOR in 1 POUCH (53329-820-09)  > 5 mL in 1 APPLICATOR",
      "NDC11Code": "76420-0517-01",
      "ProductNDC": "76420-517",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Medical Provider Single Use Ez Flu Shot Fluzone 2016-2017",
      "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) And Isopropyl Alcohol",
      "DosageFormName": "KIT",
      "RouteName": "INTRAMUSCULAR; TOPICAL",
      "StartMarketingDate": "20160701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Asclemed USA, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-11"
    },
    {
      "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": "49281-225-10",
      "PackageDescription": "10 VIAL in 1 PACKAGE (49281-225-10)  > .5 mL in 1 VIAL (49281-225-58) ",
      "NDC11Code": "49281-0225-10",
      "ProductNDC": "49281-225",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Diphtheria And Tetanus Toxoids Adsorbed",
      "NonProprietaryName": "Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20100329",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103944",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "5; 25",
      "StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100329",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. Diphtheria and Tetanus Toxoids Adsorbed is approved for use in children from 6 weeks through 6 years of age (prior to 7th birthday). Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) or a DTaP-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. Diphtheria and Tetanus Toxoids Adsorbed should be used in instances where the pertussis vaccine component is contraindicated. Diphtheria and Tetanus Toxoids Adsorbed is not to be used for treatment of diphtheria or tetanus infection.",
      "Description": "Diphtheria and Tetanus Toxoids Adsorbed is a sterile, cloudy, white, uniform suspension of diphtheria and tetanus toxoids adsorbed on aluminum phosphate and suspended in isotonic sodium chloride solution for intramuscular injection only. Diphtheria and Tetanus Toxoids Adsorbed vaccine does not contain a preservative. Each 0.5 mL dose is formulated to contain: 25 Lf diphtheria toxoid and 5 Lf tetanus toxoid. Other ingredients per 0.5 mL dose include: 1.5 mg aluminum phosphate and <100 mcg free formaldehyde. Diphtheria toxoid is prepared from the toxin produced during the growth of a selected strain of Corynebacterium diphtheriae grown with aeration in submerged culture. The toxin is purified by precipitation, converted to toxoid by the addition of formalin and concentrated by ultrafiltration. The culture medium consists of a tryptic digest of casein, supplemented with cystine, maltose, uracil, inorganic salts and vitamins. Tetanus toxoid is prepared from the toxin produced during the growth of a selected strain of Clostridium tetani. The toxin is converted to toxoid by the addition of formalin, concentrated and then purified. The culture medium consists of a tryptic digest of casein, supplemented with cystine, dextrose, uracil, inorganic salts and vitamins. When tested in guinea pigs, the tetanus and diphtheria components induce at least 2 neutralizing units/mL of serum. The vial stopper is not made with natural rubber latex."
    },
    {
      "NDCCode": "49281-312-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-312-50)  / .5 mL in 1 SYRINGE, GLASS (49281-312-88) ",
      "NDC11Code": "49281-0312-50",
      "ProductNDC": "49281-312",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone 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), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240304",
      "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/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
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      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone (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 purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone 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 2023–2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (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 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    },
    {
      "NDCCode": "49281-314-15",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-314-15)  / .5 mL in 1 VIAL, SINGLE-DOSE (49281-314-78) ",
      "NDC11Code": "49281-0314-15",
      "ProductNDC": "49281-314",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone 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), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240304",
      "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)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240304",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.",
      "Description": "Fluzone (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 purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone 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 2023–2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (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 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
    }
  ]
}
                    

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    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210204</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <ProductNDC>11673-182</ProductNDC>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200204</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>TARGET CORPORATION</LabelerName>
    <SubstanceName>BISACODYL</SubstanceName>
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    <Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <NDCCode>21695-182-25</NDCCode>
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    <NDC11Code>21695-0182-25</NDC11Code>
    <ProductNDC>21695-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thermazene</ProprietaryName>
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    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19851223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
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    <StrengthUnit>mg/g</StrengthUnit>
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    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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    <ProductNDC>25021-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefuroxime Sodium</ProprietaryName>
    <NonProprietaryName>Cefuroxime Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
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    <ApplicationNumber>ANDA064125</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>CEFUROXIME SODIUM</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: : 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp., 3 Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp., 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non- penicillinase-producing strains). .</IndicationAndUsage>
    <Description>Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>51655-182-25</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (51655-182-25)</PackageDescription>
    <NDC11Code>51655-0182-25</NDC11Code>
    <ProductNDC>51655-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hcl</ProprietaryName>
    <NonProprietaryName>Tramadol Hcl</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090404</ApplicationNumber>
    <LabelerName>Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tramadol Hydrochloride Tablets, USP are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS), reserve tramadol for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated, or are not expected to be tolerated. Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee7179b7-6a08-4eeb-a787-5d697b02c4a2.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets, USP are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Please view structure at permalink below. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. The molecular weight of tramadol hydrochloride is 299.84. Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee7179b7-6a08-4eeb-a787-5d697b02c4a2.</Description>
  </NDC>
  <NDC>
    <NDCCode>55570-182-10</NDCCode>
    <PackageDescription>25 kg in 1 BOX (55570-182-10) </PackageDescription>
    <NDC11Code>55570-0182-10</NDC11Code>
    <ProductNDC>55570-182</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Chromium Picolinate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20250310</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Jost Chemical Co.</LabelerName>
    <SubstanceName>CHROMIUM PICOLINATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>24-MAR-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>59779-182-25</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (59779-182-25)  &gt; 250 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>59779-0182-25</NDC11Code>
    <ProductNDC>59779-182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Senna Laxative</ProprietaryName>
    <ProprietaryNameSuffix>Natural Vegetable Laxative</ProprietaryNameSuffix>
    <NonProprietaryName>Sennosides</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100729</StartMarketingDate>
    <EndMarketingDate>20200729</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>SENNOSIDES</SubstanceName>
    <StrengthNumber>8.6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100729</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200729</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73377-182-03</NDCCode>
    <PackageDescription>25 g in 1 JAR (73377-182-03) </PackageDescription>
    <NDC11Code>73377-0182-03</NDC11Code>
    <ProductNDC>73377-182</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Dorzolamide Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220829</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>AX Pharmaceutical Corp</LabelerName>
    <SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>07-DEC-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>76150-182-32</NDCCode>
    <PackageDescription>4.25 g in 1 TUBE (76150-182-32)</PackageDescription>
    <NDC11Code>76150-0182-32</NDC11Code>
    <ProductNDC>76150-182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mineral Lip Tan Line</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30 Broad Spectrum</ProprietaryNameSuffix>
    <NonProprietaryName>Sunscreen</NonProprietaryName>
    <DosageFormName>LIPSTICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Bell International Laboratories, Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2.8; 1.4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>85766-182-25</NDCCode>
    <PackageDescription>250 PACKET in 1 BOX (85766-182-25)  / 1 TABLET, FILM COATED in 1 PACKET</PackageDescription>
    <NDC11Code>85766-0182-25</NDC11Code>
    <ProductNDC>85766-182</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medi-first Plus Sinus Decongestant</ProprietaryName>
    <NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260307</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Sportpharm LLC</LabelerName>
    <SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. Temporarily relieves. ■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies. ■ sinus congestion and pressure.</IndicationAndUsage>
  </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>49281-181-25</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>49281-513-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-513-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-513-00)</PackageDescription>
    <NDC11Code>49281-0513-25</NDC11Code>
    <ProductNDC>49281-513</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent</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), Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20130610</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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 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>2014-07-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-514-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-514-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-514-00)</PackageDescription>
    <NDC11Code>49281-0514-25</NDC11Code>
    <ProductNDC>49281-514</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent</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), Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20150219</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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B 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>2015-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-515-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-515-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-515-00)</PackageDescription>
    <NDC11Code>49281-0515-25</NDC11Code>
    <ProductNDC>49281-515</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/switzerland/9715293/2013 Nib-88 (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>20150626</StartMarketingDate>
    <EndMarketingDate>20160630</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/SWITZERLAND/9715293/2013 NIB-88 (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>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-516-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-516-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-516-00)</PackageDescription>
    <NDC11Code>49281-0516-25</NDC11Code>
    <ProductNDC>49281-516</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent</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>20160701</StartMarketingDate>
    <EndMarketingDate>20170630</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>2017-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>49281-517-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-517-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-517-00)</PackageDescription>
    <NDC11Code>49281-0517-25</NDC11Code>
    <ProductNDC>49281-517</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/michigan/45/2015 X-275 (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>20170701</StartMarketingDate>
    <EndMarketingDate>20180630</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (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>2018-07-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
  </NDC>
  <NDC>
    <NDCCode>49281-518-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-518-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-518-00) </PackageDescription>
    <NDC11Code>49281-0518-25</NDC11Code>
    <ProductNDC>49281-518</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20190123</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A 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>2019-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-519-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-519-25)  / .25 mL in 1 SYRINGE, GLASS (49281-519-00) </PackageDescription>
    <NDC11Code>49281-0519-25</NDC11Code>
    <ProductNDC>49281-519</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20190701</StartMarketingDate>
    <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/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 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>2024-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older.</IndicationAndUsage>
    <Description>Fluzone Quadrivalent (Influenza Vaccine) 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 Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex. Fluzone 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 7. The single-dose, pre-filled syringe (0.5 mL) is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-520-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-520-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-520-00) </PackageDescription>
    <NDC11Code>49281-0520-25</NDC11Code>
    <ProductNDC>49281-520</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 (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>20200702</StartMarketingDate>
    <EndMarketingDate>20210630</EndMarketingDate>
    <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>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200702</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-521-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-521-25)  &gt; .25 mL in 1 SYRINGE, GLASS (49281-521-00) </PackageDescription>
    <NDC11Code>49281-0521-25</NDC11Code>
    <ProductNDC>49281-521</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone Quadrivalent</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), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20210702</StartMarketingDate>
    <EndMarketingDate>20220630</EndMarketingDate>
    <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>15; 15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210702</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49281-650-25</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (49281-650-25)  &gt; .25 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>49281-0650-25</NDC11Code>
    <ProductNDC>49281-650</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Influenza A (h1n1) 2009 Monovalent Vaccine</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20090915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49281-650-70</NDCCode>
    <PackageDescription>25 SYRINGE, GLASS in 1 CARTON (49281-650-70)  &gt; .25 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>49281-0650-70</NDC11Code>
    <ProductNDC>49281-650</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Influenza A (h1n1) 2009 Monovalent Vaccine</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20090915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49281-650-90</NDCCode>
    <PackageDescription>25 SYRINGE, GLASS in 1 CARTON (49281-650-90)  &gt; .5 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>49281-0650-90</NDC11Code>
    <ProductNDC>49281-650</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Influenza A (h1n1) 2009 Monovalent Vaccine</ProprietaryName>
    <NonProprietaryName>Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20090915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>76420-517-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (76420-517-01)  *  .25 mL in 1 SYRINGE, GLASS (49281-516-00)  *  1 APPLICATOR in 1 POUCH (53329-820-09)  &gt; 5 mL in 1 APPLICATOR</PackageDescription>
    <NDC11Code>76420-0517-01</NDC11Code>
    <ProductNDC>76420-517</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Medical Provider Single Use Ez Flu Shot Fluzone 2016-2017</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) And Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INTRAMUSCULAR; TOPICAL</RouteName>
    <StartMarketingDate>20160701</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103914</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-11</LastUpdate>
  </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>49281-225-10</NDCCode>
    <PackageDescription>10 VIAL in 1 PACKAGE (49281-225-10)  &gt; .5 mL in 1 VIAL (49281-225-58) </PackageDescription>
    <NDC11Code>49281-0225-10</NDC11Code>
    <ProductNDC>49281-225</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Diphtheria And Tetanus Toxoids Adsorbed</ProprietaryName>
    <NonProprietaryName>Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20100329</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103944</ApplicationNumber>
    <LabelerName>Sanofi Pasteur Inc.</LabelerName>
    <SubstanceName>CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>5; 25</StrengthNumber>
    <StrengthUnit>[Lf]/.5mL; [Lf]/.5mL</StrengthUnit>
    <Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. Diphtheria and Tetanus Toxoids Adsorbed is approved for use in children from 6 weeks through 6 years of age (prior to 7th birthday). Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) or a DTaP-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. Diphtheria and Tetanus Toxoids Adsorbed should be used in instances where the pertussis vaccine component is contraindicated. Diphtheria and Tetanus Toxoids Adsorbed is not to be used for treatment of diphtheria or tetanus infection.</IndicationAndUsage>
    <Description>Diphtheria and Tetanus Toxoids Adsorbed is a sterile, cloudy, white, uniform suspension of diphtheria and tetanus toxoids adsorbed on aluminum phosphate and suspended in isotonic sodium chloride solution for intramuscular injection only. Diphtheria and Tetanus Toxoids Adsorbed vaccine does not contain a preservative. Each 0.5 mL dose is formulated to contain: 25 Lf diphtheria toxoid and 5 Lf tetanus toxoid. Other ingredients per 0.5 mL dose include: 1.5 mg aluminum phosphate and &lt;100 mcg free formaldehyde. Diphtheria toxoid is prepared from the toxin produced during the growth of a selected strain of Corynebacterium diphtheriae grown with aeration in submerged culture. The toxin is purified by precipitation, converted to toxoid by the addition of formalin and concentrated by ultrafiltration. The culture medium consists of a tryptic digest of casein, supplemented with cystine, maltose, uracil, inorganic salts and vitamins. Tetanus toxoid is prepared from the toxin produced during the growth of a selected strain of Clostridium tetani. The toxin is converted to toxoid by the addition of formalin, concentrated and then purified. The culture medium consists of a tryptic digest of casein, supplemented with cystine, dextrose, uracil, inorganic salts and vitamins. When tested in guinea pigs, the tetanus and diphtheria components induce at least 2 neutralizing units/mL of serum. The vial stopper is not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-312-50</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-312-50)  / .5 mL in 1 SYRINGE, GLASS (49281-312-88) </PackageDescription>
    <NDC11Code>49281-0312-50</NDC11Code>
    <ProductNDC>49281-312</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone 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), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20240304</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/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240304</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.</IndicationAndUsage>
    <Description>Fluzone (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 purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone 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 2023–2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (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 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
  </NDC>
  <NDC>
    <NDCCode>49281-314-15</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-314-15)  / .5 mL in 1 VIAL, SINGLE-DOSE (49281-314-78) </PackageDescription>
    <NDC11Code>49281-0314-15</NDC11Code>
    <ProductNDC>49281-314</ProductNDC>
    <ProductTypeName>VACCINE</ProductTypeName>
    <ProprietaryName>Fluzone 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), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20240304</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)</SubstanceName>
    <StrengthNumber>15; 15; 15</StrengthNumber>
    <StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240304</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.</IndicationAndUsage>
    <Description>Fluzone (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 purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone 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 2023–2024 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Darwin/9/2021 SAN-010 (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 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
  </NDC>
</NDCList>
                    

<NDCList><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><NDC><NDCCode>11673-182-52</NDCCode><ProprietaryName>Bisacodyl</ProprietaryName><NonProprietaryName>Biscodyl</NonProprietaryName></NDC><NDC><NDCCode>21695-182-25</NDCCode><ProprietaryName>Thermazene</ProprietaryName><NonProprietaryName>Silver Sulfadiazine</NonProprietaryName></NDC><NDC><NDCCode>25021-182-66</NDCCode><ProprietaryName>Cefuroxime Sodium</ProprietaryName><NonProprietaryName>Cefuroxime Sodium</NonProprietaryName></NDC><NDC><NDCCode>51655-182-25</NDCCode><ProprietaryName>Tramadol Hcl</ProprietaryName><NonProprietaryName>Tramadol Hcl</NonProprietaryName></NDC><NDC><NDCCode>55570-182-10</NDCCode><NonProprietaryName>Chromium Picolinate</NonProprietaryName></NDC><NDC><NDCCode>59779-182-25</NDCCode><ProprietaryName>Senna Laxative</ProprietaryName><NonProprietaryName>Sennosides</NonProprietaryName></NDC><NDC><NDCCode>73377-182-03</NDCCode><NonProprietaryName>Dorzolamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76150-182-32</NDCCode><ProprietaryName>Mineral Lip Tan Line</ProprietaryName><NonProprietaryName>Sunscreen</NonProprietaryName></NDC><NDC><NDCCode>85766-182-25</NDCCode><ProprietaryName>Medi-first Plus Sinus Decongestant</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</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>49281-181-25</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>49281-513-25</NDCCode><ProprietaryName>Fluzone Quadrivalent</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), Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-514-25</NDCCode><ProprietaryName>Fluzone Quadrivalent</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), Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-515-25</NDCCode><ProprietaryName>Fluzone Quadrivalent</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/switzerland/9715293/2013 Nib-88 (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>49281-516-25</NDCCode><ProprietaryName>Fluzone Quadrivalent</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>49281-517-25</NDCCode><ProprietaryName>Fluzone Quadrivalent</ProprietaryName><NonProprietaryName>Influenza A Virus A/michigan/45/2015 X-275 (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>49281-518-25</NDCCode><ProprietaryName>Fluzone Quadrivalent</ProprietaryName><NonProprietaryName>Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-519-25</NDCCode><ProprietaryName>Fluzone Quadrivalent Northern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-520-25</NDCCode><ProprietaryName>Fluzone Quadrivalent</ProprietaryName><NonProprietaryName>Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 (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>49281-521-25</NDCCode><ProprietaryName>Fluzone Quadrivalent</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), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-650-25</NDCCode><ProprietaryName>Influenza A (h1n1) 2009 Monovalent Vaccine</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-650-70</NDCCode><ProprietaryName>Influenza A (h1n1) 2009 Monovalent Vaccine</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-650-90</NDCCode><ProprietaryName>Influenza A (h1n1) 2009 Monovalent Vaccine</ProprietaryName><NonProprietaryName>Influenza A Virus A/california/7/2009(h1n1)-like Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>76420-517-01</NDCCode><ProprietaryName>Medical Provider Single Use Ez Flu Shot Fluzone 2016-2017</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) And Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>49281-026-50</NDCCode><ProprietaryName>Nuvaxovid 2026-27</ProprietaryName><NonProprietaryName>Nvx-cov2928</NonProprietaryName></NDC><NDC><NDCCode>49281-225-10</NDCCode><ProprietaryName>Diphtheria And Tetanus Toxoids Adsorbed</ProprietaryName><NonProprietaryName>Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-312-50</NDCCode><ProprietaryName>Fluzone 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), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>49281-314-15</NDCCode><ProprietaryName>Fluzone 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), And Influenza B Virus B/michigan/01/2021 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",
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      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "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"
    },
    {
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}
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