RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "58160-830-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-830-52)  > .5 mL in 1 SYRINGE (58160-830-43)",
      "NDC11Code": "58160-0830-52",
      "ProductNDC": "58160-830",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Cervarix",
      "NonProprietaryName": "Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20091016",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125259",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN",
      "StrengthNumber": "20; 20",
      "StrengthUnit": "ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "58160-830-34",
      "PackageDescription": "1 SYRINGE in 1 CARTON (58160-830-34)  > .5 mL in 1 SYRINGE (58160-830-05)",
      "NDC11Code": "58160-0830-34",
      "ProductNDC": "58160-830",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Cervarix",
      "NonProprietaryName": "Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20091016",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125259",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN",
      "StrengthNumber": "20; 20",
      "StrengthUnit": "ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "51655-830-52",
      "PackageDescription": "30 TABLET in 1 BOTTLE (51655-830-52)",
      "NDC11Code": "51655-0830-52",
      "ProductNDC": "51655-830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline",
      "NonProprietaryName": "Sertraline",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Northwind Pharmaceuticals, LLC",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY). 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=cf71d1b9-5ebb-429f-a07f-a87cd168250f.",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride, USP has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula is C17H17NCl2HCl. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate. 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=cf71d1b9-5ebb-429f-a07f-a87cd168250f."
    },
    {
      "NDCCode": "58160-725-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-725-52)  / .5 mL in 1 SYRINGE (58160-725-41) ",
      "NDC11Code": "58160-0725-52",
      "ProductNDC": "58160-725",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix",
      "ProprietaryNameSuffix": "2026/2027",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20260701",
      "EndMarketingDate": "20270630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20260701",
      "EndMarketingDatePackage": "20270630",
      "SamplePackage": "N",
      "IndicationAndUsage": "FLUARIX is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see Description (11)]. FLUARIX is approved for use in persons aged 6 months and older.",
      "Description": "FLUARIX, Influenza Vaccine, is a sterile colorless and slightly opalescent injectable suspension for intramuscular use. FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus‑containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate‑buffered isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus solutions. FLUARIX is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5‑mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/Switzerland/6849/2025 IVR‑278 (an A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Michigan/105/2025 SAN-049A (an A/Darwin/1454/2025‑like virus) (H3N2), and B/Tokyo/EIS13‑175/2025 (B‑Victoria lineage). These three influenza virus strains are recommended by FDA for the 2026‑2027 influenza season. FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal. Each 0.5‑mL dose also contains octoxinol‑10 (TRITON X‑100) ≤0.085 mg, α‑tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0015 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-810-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-810-52)  / .5 mL in 1 SYRINGE (58160-810-43) ",
      "NDC11Code": "58160-0810-52",
      "ProductNDC": "58160-810",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Infanrix",
      "NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090724",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103647",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "10; 25; 25; 25; 8",
      "StrengthUnit": "[iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090724",
      "SamplePackage": "N",
      "IndicationAndUsage": "INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday).",
      "Description": "INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), and 8 mcg of pertactin (69 kiloDalton outer membrane protein). The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and 4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. INFANRIX is formulated without preservatives."
    },
    {
      "NDCCode": "58160-811-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-811-52)  / .5 mL in 1 SYRINGE (58160-811-43) ",
      "NDC11Code": "58160-0811-52",
      "ProductNDC": "58160-811",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Pediarix",
      "NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090724",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103907",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "25; 10; 25; 25; 8; 10; 40; 8; 32",
      "StrengthUnit": "[iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090724",
      "SamplePackage": "N",
      "IndicationAndUsage": "PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).",
      "Description": "PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 10 mcg of HBsAg, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components are the same as those in INFANRIX and KINRIX. The hepatitis B surface antigen is the same as that in ENGERIX-B. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. The hepatitis B surface antigen is obtained by culturing genetically engineered Saccharomyces cerevisiae (S. cerevisiae) cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic medium. The surface antigen expressed in the S. cerevisiae cells is purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration. The inactivated poliovirus component is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor present an undue risk for BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The hepatitis B component is adsorbed onto aluminum phosphate. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis component (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Potency of the hepatitis B component is established by HBsAg ELISA. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus-neutralizing cell culture assay on sera from previously immunized rats. Each 0.5 mL dose contains aluminum hydroxide and aluminum phosphate as adjuvants (formulated to contain 0.7 mg aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The procedures used to manufacture the HBsAg antigen result in a product that contains ≤5% yeast protein. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. PEDIARIX is formulated without preservatives."
    },
    {
      "NDCCode": "58160-812-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-812-52)  / .5 mL in 1 SYRINGE (58160-812-43) ",
      "NDC11Code": "58160-0812-52",
      "ProductNDC": "58160-812",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Kinrix",
      "NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20080709",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125260",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "25; 10; 25; 8; 25; 40; 8; 32",
      "StrengthUnit": "[iU]/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20080709",
      "SamplePackage": "N",
      "IndicationAndUsage": "A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.",
      "Description": "KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D‑antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF‑1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The inactivated poliovirus component of KINRIX is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus-neutralizing cell culture assay on sera from previously immunized rats. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. KINRIX does not contain a preservative."
    },
    {
      "NDCCode": "58160-815-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-815-52)  / 1 mL in 1 SYRINGE (58160-815-43) ",
      "NDC11Code": "58160-0815-52",
      "ProductNDC": "58160-815",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Twinrix",
      "NonProprietaryName": "Hepatitis A And Hepatitis B (recombinant) Vaccine",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070607",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103850",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "720; 20",
      "StrengthUnit": "[iU]/mL; ug/mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070607",
      "SamplePackage": "N",
      "IndicationAndUsage": "TWINRIX is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. TWINRIX is approved for use in persons 18 years of age or older.",
      "Description": "TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine containing the antigenic components used in producing HAVRIX (Hepatitis A Vaccine) and ENGERIX‑B [Hepatitis B Vaccine (Recombinant)]. TWINRIX is a sterile, injectable suspension for intramuscular use that contains inactivated hepatitis A virus (strain HM175) and noninfectious HBsAg. The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells, which carry the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation. A 1 mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, sodium chloride, phosphate buffer, polysorbate 20, and Water for Injection. From the manufacturing process, each 1 mL dose of TWINRIX also contains residual formalin (not more than 0.1 mg), MRC-5 cellular proteins (not more than 2.5 mcg), neomycin sulfate (an aminoglycoside antibiotic included in the cell growth media; not more than 20 ng), and yeast protein (no more than 5%). TWINRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. TWINRIX is formulated without preservatives."
    },
    {
      "NDCCode": "58160-820-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-820-52)  / .5 mL in 1 SYRINGE (58160-820-43) ",
      "NDC11Code": "58160-0820-52",
      "ProductNDC": "58160-820",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Engerix-b",
      "NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070425",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103239",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "10",
      "StrengthUnit": "ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070425",
      "SamplePackage": "N",
      "IndicationAndUsage": "ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.",
      "Description": "ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives."
    },
    {
      "NDCCode": "58160-821-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-821-52)  / 1 mL in 1 SYRINGE (58160-821-43) ",
      "NDC11Code": "58160-0821-52",
      "ProductNDC": "58160-821",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Engerix-b",
      "NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070328",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103239",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/mL",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070328",
      "SamplePackage": "N",
      "IndicationAndUsage": "ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.",
      "Description": "ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives."
    },
    {
      "NDCCode": "58160-825-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-825-52)  / .5 mL in 1 SYRINGE (58160-825-43) ",
      "NDC11Code": "58160-0825-52",
      "ProductNDC": "58160-825",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Havrix",
      "NonProprietaryName": "Hepatitis A Vaccine",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070216",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103475",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "720",
      "StrengthUnit": "[iU]/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070216",
      "SamplePackage": "N",
      "IndicationAndUsage": "HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.",
      "Description": "HAVRIX (Hepatitis A Vaccine) is a sterile, injectable suspension of inactivated virus for intramuscular use. The virus (strain HM175) is propagated in MRC‑5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5 mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-826-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-826-52)  / 1 mL in 1 SYRINGE (58160-826-43) ",
      "NDC11Code": "58160-0826-52",
      "ProductNDC": "58160-826",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Havrix",
      "NonProprietaryName": "Hepatitis A Vaccine",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20070413",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103475",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "1440",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20070413",
      "SamplePackage": "N",
      "IndicationAndUsage": "HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.",
      "Description": "HAVRIX (Hepatitis A Vaccine) is a sterile, injectable suspension of inactivated virus for intramuscular use. The virus (strain HM175) is propagated in MRC‑5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5 mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-842-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-842-52)  / .5 mL in 1 SYRINGE (58160-842-43) ",
      "NDC11Code": "58160-0842-52",
      "ProductNDC": "58160-842",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Boostrix",
      "NonProprietaryName": "Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20090724",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125106",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "5; 2.5; 8; 8; 2.5",
      "StrengthUnit": "[iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090724",
      "SamplePackage": "N",
      "IndicationAndUsage": "BOOSTRIX is indicated for: 1 active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older,, 2 immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.",
      "Description": "BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, injectable suspension for intramuscular use. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde‑treated FHA and PRN). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and PRN) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; PRN is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and PRN are treated with formaldehyde. Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5 mL dose is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 mcg of inactivated PT, 8 mcg of FHA, and 2.5 mcg of PRN (69 kiloDalton outer membrane protein). Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde‑treated FHA and PRN) is determined by enzyme‑linked immunosorbent assay (ELISA) on sera from previously immunized mice. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.3 mg aluminum) and 4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). BOOSTRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. BOOSTRIX is formulated without preservatives."
    },
    {
      "NDCCode": "58160-849-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-849-52)  / .5 mL in 1 SYRINGE (58160-849-43) ",
      "NDC11Code": "58160-0849-52",
      "ProductNDC": "58160-849",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Shingrix",
      "NonProprietaryName": "Zoster Vaccine Recombinant, Adjuvanted",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20250716",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125614",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/.5mL",
      "Status": "Active",
      "LastUpdate": "2026-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250716",
      "SamplePackage": "N",
      "IndicationAndUsage": "SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): 1 in adults aged 50 years and older., 2 in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.",
      "Description": "SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is a sterile injectable suspension for intramuscular use that contains recombinant varicella zoster virus gE antigen adjuvanted with AS01B. The vial and vial presentation is supplied as a vial of lyophilized recombinant varicella zoster virus surface gE antigen component (Lyophilized gE Antigen Component), which must be reconstituted at the time of use with the accompanying vial of AS01B (Adjuvant Suspension Component) to form SHINGRIX. The SHINGRIX prefilled syringe presentation does not require reconstitution. SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid. The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal‑derived proteins. The gE protein is purified by several chromatographic steps and formulated with excipients. The AS01B adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) derived from Salmonella minnesota and QS‑21, a saponin purified from Quillaja saponaria Molina plant extract, and is combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. Each 0.5‑mL dose is formulated to contain 50 mcg of the recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS‑21. Each dose also contains 20 mg of sucrose, 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate (applicable to prefilled syringe presentation only), 0.160 mg of sodium dihydrogen phosphate anhydrous (applicable to vial and vial presentation only), 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. SHINGRIX does not contain preservatives. Each dose may also contain residual amounts of host cell proteins (≤3.0%) and DNA (≤2.1 picograms) from the manufacturing process. In the vial and vial presentation, the vial stoppers are not made with natural rubber latex. In the prefilled syringe presentation, the tip cap and rubber plunger stopper are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-854-52",
      "PackageDescription": "1 KIT in 1 CARTON (58160-854-52)  *  10 VIAL in 1 CARTON (58160-851-10)  / 1 mL in 1 VIAL (58160-851-01)  *  1 mL in 1 APPLICATOR (58160-853-02) ",
      "NDC11Code": "58160-0854-52",
      "ProductNDC": "58160-854",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Rotarix",
      "NonProprietaryName": "Rotavirus Vaccine, Live, Oral",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20110113",
      "EndMarketingDate": "20250224",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125265",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110113",
      "EndMarketingDatePackage": "20250224",
      "SamplePackage": "N",
      "IndicationAndUsage": "ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.",
      "Description": "ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. There are two formulations of ROTARIX: a reconstituted lyophilized formulation (supplied in a vial and oral dosing applicator presentation) and a liquid formulation (supplied in an oral dosing applicator only presentation). Formulation for the Vial and Oral Dosing Applicator Presentation. After reconstitution of the lyophilized vaccine component, each 1 mL dose of the ROTARIX formulation for the vial and oral dosing applicator presentation contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine component of this ROTARIX formulation contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in this ROTARIX formulation. PCV-1 is not known to cause disease in humans. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral dosing applicator of liquid diluent [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex; the vial stoppers are not made with natural rubber latex. This ROTARIX formulation contains no preservatives. Formulation for the Oral Dosing Applicator Only Presentation. Each 1.5 mL dose of the ROTARIX formulation for the oral dosing applicator only presentation contains at least 106.0 CCID50 of live, attenuated rotavirus. This ROTARIX formulation contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. This ROTARIX formulation contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex. This ROTARIX formulation contains no preservatives."
    },
    {
      "NDCCode": "58160-880-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-880-52)  > .5 mL in 1 SYRINGE (58160-880-41)",
      "NDC11Code": "58160-0880-52",
      "ProductNDC": "58160-880",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix",
      "ProprietaryNameSuffix": "2013/2014",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-28"
    },
    {
      "NDCCode": "58160-881-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-881-52)  > .5 mL in 1 SYRINGE (58160-881-41)",
      "NDC11Code": "58160-0881-52",
      "ProductNDC": "58160-881",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix",
      "ProprietaryNameSuffix": "2014/2015",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20140627",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-24"
    },
    {
      "NDCCode": "58160-884-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-884-52)  / .5 mL in 1 SYRINGE (58160-884-41) ",
      "NDC11Code": "58160-0884-52",
      "ProductNDC": "58160-884",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix",
      "ProprietaryNameSuffix": "2024/2025",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240701",
      "EndMarketingDate": "20250630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240701",
      "EndMarketingDatePackage": "20250630",
      "SamplePackage": "N",
      "IndicationAndUsage": "FLUARIX is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see Description (11)]. FLUARIX is approved for use in persons aged 6 months and older.",
      "Description": "FLUARIX, Influenza Vaccine, is a sterile colorless and slightly opalescent injectable suspension for intramuscular use. FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus solutions. FLUARIX has been standardized according to U.S. Public Health Service (USPHS) requirements for the 2024‑2025 influenza season and is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5‑mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/Victoria/4897/2022 (H1N1) IVR-238, A/Thailand/8/2022 (H3N2) IVR-237 and, B/Austria/1359417/2021 BVR-26 (B-Victoria lineage). FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal. Each 0.5‑mL dose also contains octoxinol-10 (TRITON X-100) ≤0.085 mg, α-tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0015 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-885-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-885-52)  > .5 mL in 1 SYRINGE (58160-885-41) ",
      "NDC11Code": "58160-0885-52",
      "ProductNDC": "58160-885",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2020/2021",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20200702",
      "EndMarketingDate": "20210630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 NIB-121 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 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": "58160-887-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-887-52)  > .5 mL in 1 SYRINGE (58160-887-41) ",
      "NDC11Code": "58160-0887-52",
      "ProductNDC": "58160-887",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2021/2022",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20210702",
      "EndMarketingDate": "20220630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "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": "58160-890-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-890-52)  / .5 mL in 1 SYRINGE (58160-890-41) ",
      "NDC11Code": "58160-0890-52",
      "ProductNDC": "58160-890",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2022/2023",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20220701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-07-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20220701",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58160-896-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-896-52)  > .5 mL in 1 SYRINGE (58160-896-41) ",
      "NDC11Code": "58160-0896-52",
      "ProductNDC": "58160-896",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2019/2020",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20190702",
      "EndMarketingDate": "20200630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190702",
      "EndMarketingDatePackage": "20200630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58160-898-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-898-52)  > .5 mL in 1 SYRINGE (58160-898-41) ",
      "NDC11Code": "58160-0898-52",
      "ProductNDC": "58160-898",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2018/2019",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20180629",
      "EndMarketingDate": "20190630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180629",
      "EndMarketingDatePackage": "20190630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58160-900-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-900-52)  > .5 mL in 1 SYRINGE (58160-900-41)",
      "NDC11Code": "58160-0900-52",
      "ProductNDC": "58160-900",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2013/2014",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20130701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-07"
    },
    {
      "NDCCode": "58160-901-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-901-52)  > .5 mL in 1 SYRINGE (58160-901-41)",
      "NDC11Code": "58160-0901-52",
      "ProductNDC": "58160-901",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2014/2015",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20140701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-17"
    },
    {
      "NDCCode": "58160-903-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-903-52)  > .5 mL in 1 SYRINGE (58160-903-41)",
      "NDC11Code": "58160-0903-52",
      "ProductNDC": "58160-903",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2015/2016",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20150701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "58160-905-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-905-52)  > .5 mL in 1 SYRINGE (58160-905-41)",
      "NDC11Code": "58160-0905-52",
      "ProductNDC": "58160-905",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2016/2017",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20160701",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "58160-907-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-907-52)  > .5 mL in 1 SYRINGE (58160-907-41) ",
      "NDC11Code": "58160-0907-52",
      "ProductNDC": "58160-907",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2017/2018",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20170707",
      "EndMarketingDate": "20180630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (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": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170707",
      "EndMarketingDatePackage": "20180630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58160-909-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-909-52)  / .5 mL in 1 SYRINGE (58160-909-41) ",
      "NDC11Code": "58160-0909-52",
      "ProductNDC": "58160-909",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix Quadrivalent",
      "ProprietaryNameSuffix": "2023/2024",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20230630",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230630",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "FLUARIX QUADRIVALENT is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine [see Description (11)]. FLUARIX QUADRIVALENT is approved for use in persons aged 6 months and older.",
      "Description": "FLUARIX QUADRIVALENT, Influenza Vaccine, for intramuscular injection, is a sterile, colorless, and slightly opalescent suspension. FLUARIX QUADRIVALENT is prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate-buffered isotonic sodium chloride solution. Each vaccine is formulated from the split inactivated virus solutions. FLUARIX QUADRIVALENT has been standardized according to U.S. Public Health Service (USPHS) requirements for the 2023-2024 influenza season and is formulated to contain 60 micrograms (mcg) hemagglutinin (HA) per 0.5‑mL dose, in the recommended ratio of 15 mcg HA of each of the following 4 influenza virus strains (2 A strains and 2 B strains): A/Victoria/4897/2022 (H1N1) IVR-238, A/Darwin/6/2021 (H3N2) IVR-227 (an A/Darwin/9/2021 (H3N2)-like virus), B/Austria/1359417/2021 BVR-26 (B-Victoria lineage), and B/Phuket/3073/2013 (B-Yamagata lineage). FLUARIX QUADRIVALENT is formulated without preservatives. FLUARIX QUADRIVALENT does not contain thimerosal. Each 0.5‑mL dose also contains octoxynol-10 (TRITON X-100) ≤0.115 mg, α-tocopheryl hydrogen succinate ≤0.135 mg, and polysorbate 80 (Tween 80) ≤0.550 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0015 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.050 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤65 mcg from the manufacturing process. The tip caps and plungers of the prefilled syringes of FLUARIX QUADRIVALENT are not made with natural rubber latex."
    },
    {
      "NDCCode": "58160-912-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-912-52)  / .5 mL in 1 SYRINGE (58160-912-41) ",
      "NDC11Code": "58160-0912-52",
      "ProductNDC": "58160-912",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluarix",
      "ProprietaryNameSuffix": "2025/2026",
      "NonProprietaryName": "Influenza Virus Vaccine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20250701",
      "EndMarketingDate": "20260630",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125127",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250701",
      "EndMarketingDatePackage": "20260630",
      "SamplePackage": "N",
      "IndicationAndUsage": "FLUARIX is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see Description (11)]. FLUARIX is approved for use in persons aged 6 months and older.",
      "Description": "FLUARIX, Influenza Vaccine, is a sterile colorless and slightly opalescent injectable suspension for intramuscular use. FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus solutions. FLUARIX has been standardized according to U.S. Public Health Service (USPHS) requirements for the 2025‑2026 influenza season and is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5‑mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/Victoria/4897/2022 (H1N1) IVR‑238, A/Croatia/10136RV/2023 (H3N2) X‑425A, and B/Austria/1359417/2021 BVR‑26 (B‑Victoria lineage). FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal. Each 0.5‑mL dose also contains octoxinol-10 (TRITON X-100) ≤0.085 mg, α-tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0015 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"58160-830-52","ProprietaryName":"Cervarix","NonProprietaryName":"Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant"},{"NDCCode":"58160-830-34","ProprietaryName":"Cervarix","NonProprietaryName":"Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant"},{"NDCCode":"51655-830-52","ProprietaryName":"Sertraline","NonProprietaryName":"Sertraline"},{"NDCCode":"58160-725-52","ProprietaryName":"Fluarix","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-810-52","ProprietaryName":"Infanrix","NonProprietaryName":"Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed"},{"NDCCode":"58160-811-52","ProprietaryName":"Pediarix","NonProprietaryName":"Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined"},{"NDCCode":"58160-812-52","ProprietaryName":"Kinrix","NonProprietaryName":"Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine"},{"NDCCode":"58160-815-52","ProprietaryName":"Twinrix","NonProprietaryName":"Hepatitis A And Hepatitis B (recombinant) Vaccine"},{"NDCCode":"58160-820-52","ProprietaryName":"Engerix-b","NonProprietaryName":"Hepatitis B Vaccine (recombinant)"},{"NDCCode":"58160-821-52","ProprietaryName":"Engerix-b","NonProprietaryName":"Hepatitis B Vaccine (recombinant)"},{"NDCCode":"58160-825-52","ProprietaryName":"Havrix","NonProprietaryName":"Hepatitis A Vaccine"},{"NDCCode":"58160-826-52","ProprietaryName":"Havrix","NonProprietaryName":"Hepatitis A Vaccine"},{"NDCCode":"58160-842-52","ProprietaryName":"Boostrix","NonProprietaryName":"Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed"},{"NDCCode":"58160-849-52","ProprietaryName":"Shingrix","NonProprietaryName":"Zoster Vaccine Recombinant, Adjuvanted"},{"NDCCode":"58160-854-52","ProprietaryName":"Rotarix","NonProprietaryName":"Rotavirus Vaccine, Live, Oral"},{"NDCCode":"58160-880-52","ProprietaryName":"Fluarix","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-881-52","ProprietaryName":"Fluarix","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-884-52","ProprietaryName":"Fluarix","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-885-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-887-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-890-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-896-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-898-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-900-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-901-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-903-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-905-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-907-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-909-52","ProprietaryName":"Fluarix Quadrivalent","NonProprietaryName":"Influenza Virus Vaccine"},{"NDCCode":"58160-912-52","ProprietaryName":"Fluarix","NonProprietaryName":"Influenza Virus Vaccine"}]}
                    

<NDCList><NDC><NDCCode>58160-830-52</NDCCode><ProprietaryName>Cervarix</ProprietaryName><NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName></NDC><NDC><NDCCode>58160-830-34</NDCCode><ProprietaryName>Cervarix</ProprietaryName><NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName></NDC><NDC><NDCCode>51655-830-52</NDCCode><ProprietaryName>Sertraline</ProprietaryName><NonProprietaryName>Sertraline</NonProprietaryName></NDC><NDC><NDCCode>58160-725-52</NDCCode><ProprietaryName>Fluarix</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-810-52</NDCCode><ProprietaryName>Infanrix</ProprietaryName><NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed</NonProprietaryName></NDC><NDC><NDCCode>58160-811-52</NDCCode><ProprietaryName>Pediarix</ProprietaryName><NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined</NonProprietaryName></NDC><NDC><NDCCode>58160-812-52</NDCCode><ProprietaryName>Kinrix</ProprietaryName><NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-815-52</NDCCode><ProprietaryName>Twinrix</ProprietaryName><NonProprietaryName>Hepatitis A And Hepatitis B (recombinant) Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-820-52</NDCCode><ProprietaryName>Engerix-b</ProprietaryName><NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>58160-821-52</NDCCode><ProprietaryName>Engerix-b</ProprietaryName><NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName></NDC><NDC><NDCCode>58160-825-52</NDCCode><ProprietaryName>Havrix</ProprietaryName><NonProprietaryName>Hepatitis A Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-826-52</NDCCode><ProprietaryName>Havrix</ProprietaryName><NonProprietaryName>Hepatitis A Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-842-52</NDCCode><ProprietaryName>Boostrix</ProprietaryName><NonProprietaryName>Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed</NonProprietaryName></NDC><NDC><NDCCode>58160-849-52</NDCCode><ProprietaryName>Shingrix</ProprietaryName><NonProprietaryName>Zoster Vaccine Recombinant, Adjuvanted</NonProprietaryName></NDC><NDC><NDCCode>58160-854-52</NDCCode><ProprietaryName>Rotarix</ProprietaryName><NonProprietaryName>Rotavirus Vaccine, Live, Oral</NonProprietaryName></NDC><NDC><NDCCode>58160-880-52</NDCCode><ProprietaryName>Fluarix</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-881-52</NDCCode><ProprietaryName>Fluarix</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-884-52</NDCCode><ProprietaryName>Fluarix</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-885-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-887-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-890-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-896-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-898-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-900-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-901-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-903-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-905-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-907-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-909-52</NDCCode><ProprietaryName>Fluarix Quadrivalent</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC><NDC><NDCCode>58160-912-52</NDCCode><ProprietaryName>Fluarix</ProprietaryName><NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName></NDC></NDCList>