{
"NDC": [
{
"NDCCode": "58160-823-11",
"PackageDescription": "1 KIT in 1 CARTON (58160-823-11) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03) ",
"NDC11Code": "58160-0823-11",
"ProductNDC": "58160-823",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Shingrix",
"NonProprietaryName": "Zoster Vaccine Recombinant, Adjuvanted",
"DosageFormName": "KIT",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125614",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171020",
"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": "49884-823-11",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-823-11) ",
"NDC11Code": "49884-0823-11",
"ProductNDC": "49884-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120628",
"EndMarketingDate": "20190228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078783",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120628",
"EndMarketingDatePackage": "20190228",
"SamplePackage": "N"
},
{
"NDCCode": "50268-823-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-823-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-823-11) ",
"NDC11Code": "50268-0823-15",
"ProductNDC": "50268-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077670",
"LabelerName": "AvPAK",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251009",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 112.0 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Ascorbic acid (in 25 mg, 50 mg and 100 mg tablets), D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance."
},
{
"NDCCode": "60687-823-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-823-01) / 1 TABLET in 1 BLISTER PACK (60687-823-11) ",
"NDC11Code": "60687-0823-01",
"ProductNDC": "60687-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078888",
"LabelerName": "American Health Packaging",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. .",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet)."
},
{
"NDCCode": "68084-823-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-823-21) / 1 TABLET in 1 BLISTER PACK (68084-823-11) ",
"NDC11Code": "68084-0823-21",
"ProductNDC": "68084-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040300",
"LabelerName": "American Health Packaging",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140930",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a CNS stimulant. They are available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc. Note: Methylphenidate hydrochloride tablets are color-additive free."
},
{
"NDCCode": "58160-801-11",
"PackageDescription": "1 KIT in 1 CARTON (58160-801-11) * 10 VIAL in 1 CARTON (58160-809-05) > .5 mL in 1 VIAL (58160-809-01)",
"NDC11Code": "58160-0801-11",
"ProductNDC": "58160-801",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Menhibrix",
"NonProprietaryName": "Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20130903",
"EndMarketingDate": "20170917",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125363",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
},
{
"NDCCode": "58160-810-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-810-11) > .5 mL in 1 VIAL (58160-810-01) ",
"NDC11Code": "58160-0810-11",
"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": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "25; 8; 25; 10; 25",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.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], 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": "Deprecated",
"LastUpdate": "2022-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090724",
"SamplePackage": "N"
},
{
"NDCCode": "58160-812-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-812-11) > .5 mL in 1 VIAL (58160-812-01) ",
"NDC11Code": "58160-0812-11",
"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": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "25; 8; 25; 10; 25; 40; 8; 32",
"StrengthUnit": "[iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.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": "Deprecated",
"LastUpdate": "2022-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20080709",
"SamplePackage": "N"
},
{
"NDCCode": "58160-815-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-815-11) > 1 mL in 1 VIAL (58160-815-01)",
"NDC11Code": "58160-0815-11",
"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": "Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-12",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "58160-818-11",
"PackageDescription": "1 KIT in 1 CARTON (58160-818-11) * 10 VIAL in 1 CARTON (58160-816-05) / .5 mL in 1 VIAL (58160-816-01) * 10 VIAL in 1 PACKAGE (58160-817-05) / .85 mL in 1 VIAL (58160-817-01) ",
"NDC11Code": "58160-0818-11",
"ProductNDC": "58160-818",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Hiberix",
"NonProprietaryName": "Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)",
"DosageFormName": "KIT",
"StartMarketingDate": "20151221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125347",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151221",
"SamplePackage": "N",
"IndicationAndUsage": "HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).",
"Description": "HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a solution for intramuscular injection, supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. HIBERIX contains Haemophilus b capsular polysaccharide (polyribosyl‑ribitol‑phosphate [PRP]), a high molecular weight polymer prepared from the H. influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi‑synthetic medium, is detoxified with formaldehyde and purified. The capsular polysaccharide is covalently bound to the tetanus toxoid. After purification, the conjugate is lyophilized in the presence of lactose as a stabilizer. The diluent for HIBERIX is a sterile saline solution (0.9% sodium chloride) supplied in prefilled syringes. After reconstitution, each approximately 0.5‑mL dose of HIBERIX contains 10 mcg of purified capsular polysaccharide conjugated to approximately 25 mcg of tetanus toxoid, 12.6 mg of lactose, and ≤0.5 mcg of residual formaldehyde. HIBERIX does not contain a preservative. The stopper of the vial containing Lyophilized Antigen Component and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex."
},
{
"NDCCode": "58160-820-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-820-11) > .5 mL in 1 VIAL (58160-820-01) ",
"NDC11Code": "58160-0820-11",
"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": "Deprecated",
"LastUpdate": "2019-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20070425",
"SamplePackage": "N"
},
{
"NDCCode": "58160-821-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-821-11) / 1 mL in 1 VIAL (58160-821-01) ",
"NDC11Code": "58160-0821-11",
"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": "58160-825-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-825-11) > .5 mL in 1 VIAL (58160-825-01) ",
"NDC11Code": "58160-0825-11",
"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": "Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [CS],Vaccines, Inactivated [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20070216",
"SamplePackage": "N"
},
{
"NDCCode": "58160-826-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-826-11) > 1 mL in 1 VIAL (58160-826-01) ",
"NDC11Code": "58160-0826-11",
"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": "Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [CS],Vaccines, Inactivated [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20070413",
"SamplePackage": "N"
},
{
"NDCCode": "58160-842-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-842-11) / .5 mL in 1 VIAL (58160-842-01) ",
"NDC11Code": "58160-0842-11",
"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": "8; 2.5; 8; 5; 2.5",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.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], 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": "Deprecated",
"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 vials 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. BOOSTRIX is formulated without preservatives."
},
{
"NDCCode": "58160-848-11",
"PackageDescription": "1 KIT in 1 CARTON (58160-848-11) * .5 mL in 1 VIAL (58160-723-03) * .5 mL in 1 VIAL (58160-744-03) ",
"NDC11Code": "58160-0848-11",
"ProductNDC": "58160-848",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Arexvy",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted",
"DosageFormName": "KIT",
"StartMarketingDate": "20230503",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125775",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230503",
"SamplePackage": "N",
"IndicationAndUsage": "AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex."
},
{
"NDCCode": "50090-3096-0",
"PackageDescription": "1 KIT in 1 KIT (50090-3096-0) * 1 mL in 1 VIAL, GLASS (58160-966-01) * 1 mL in 1 SYRINGE (58160-967-02) ",
"NDC11Code": "50090-3096-00",
"ProductNDC": "50090-3096",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Rabavert",
"NonProprietaryName": "Rabies Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20161219",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103334",
"LabelerName": "A-S Medication Solutions",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20161219",
"SamplePackage": "N",
"IndicationAndUsage": "RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually an immunization series is initiated and completed with 1 vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV.4,11.",
"Description": "RabAvert Rabies Vaccine produced by GlaxoSmithKline GmbH is a sterile, freeze-dried vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The strain Flury LEP was obtained from American Type Culture Collection as the 59th egg passage. The growth medium for propagation of the virus is a synthetic cell culture medium with the addition of human albumin, polygeline (processed bovine gelatin), and antibiotics. The virus is inactivated with β-propiolactone and further processed by zonal centrifugation in a sucrose density gradient. The vaccine is lyophilized after addition of a stabilizer solution that consists of buffered polygeline and potassium glutamate. One dose of reconstituted vaccine contains ≤12 mg polygeline (processed bovine gelatin), ≤0.3 mg human serum albumin, 1 mg potassium glutamate, and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia, and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumin content is ≤3 ng/dose (1 mL), based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin B) added during cell and virus propagation are largely removed during subsequent steps in the manufacturing process. In the final vaccine, neomycin is present at ≤10 mcg, chlortetracycline at ≤200 ng, and amphotericin B at ≤20 ng per dose. RabAvert is intended for intramuscular (IM) injection. The vaccine contains no preservative and should be used immediately after reconstitution with the supplied Sterile Diluent for RabAvert (Water for Injection). The potency of the final product is determined by the National Institutes of Health (NIH) mouse potency test using the United States (US) reference standard. The potency of 1 dose (1.0 mL) of RabAvert is at least 2.5 IU of rabies antigen. RabAvert is a white, freeze-dried vaccine for reconstitution with the diluent prior to use; the reconstituted vaccine is a clear to slightly opalescent, colorless to slightly pink suspension."
},
{
"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": "58160-742-25",
"PackageDescription": "1 KIT in 1 CARTON (58160-742-25) * 10 VIAL in 1 CARTON (58160-753-19) / 2.5 mL in 1 VIAL (58160-753-01) * 10 VIAL in 1 CARTON (58160-855-19) / 2.5 mL in 1 VIAL (58160-855-01) ",
"NDC11Code": "58160-0742-25",
"ProductNDC": "58160-742",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Arepanrix",
"NonProprietaryName": "Influenza A H5 Monovalent Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20260511",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125419",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260511",
"SamplePackage": "N",
"IndicationAndUsage": "AREPANRIX is indicated for active immunization for the prevention of disease caused by the influenza A virus H5 subtype contained in the vaccine. AREPANRIX is approved for use in individuals 6 months of age and older at increased risk of exposure to the influenza A virus H5 subtype contained in the vaccine. In individuals 6 months through 17 years of age, this indication is approved under accelerated approval based on immune responses, as measured by hemagglutination‑inhibition (HI) titers [see Clinical Studies (14.2)]. Continued approval for this indication in individuals 6 months through 17 years of age may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
"Description": "AREPANRIX (Influenza A [H5] Monovalent Vaccine, Adjuvanted) is a sterile injectable emulsion administered intramuscularly. The vaccine is supplied as 2 components: a vial of inactivated, split-virion, H5 Antigen Component and a vial of AS03 Adjuvant Component that must be combined prior to administration to form AREPANRIX. The H5 Antigen Component is manufactured according to a similar process as that used to produce the antigens contained in FLULAVAL (Influenza Vaccine) and FLULAVAL QUADRIVALENT (Influenza Vaccine), which are unadjuvanted seasonal influenza vaccines licensed in the U.S. The H5 Antigen Component is a sterile, translucent to whitish opalescent suspension in a phosphate-buffered, thimerosal‑containing saline solution that may sediment slightly. The sediment resuspends upon mixing by inversion to form a homogeneous suspension. The H5 Antigen Component is prepared from virus propagated in the allantoic cavity of embryonated hen’s eggs. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate. The AS03 Adjuvant Component is a homogenized, sterile, whitish to yellowish milky emulsion composed of squalene, DL-α-tocopherol, and polysorbate 80. AREPANRIX is prepared by combining the H5 Antigen Component with the AS03 Adjuvant Component. After combining, AREPANRIX is a whitish to yellowish homogenous milky emulsion. Each 0.5‑mL dose of AREPANRIX (H5N8) for individuals 18 years of age and older contains 3.75 mcg hemagglutinin (HA) of the influenza virus strain A/Astrakhan/3212/2020-like (H5N8, clade 2.3.4.4b); 5 mcg thimerosal, a mercury derivative, as a preservative (2.5 mcg mercury); and AS03 adjuvant (10.69 mg squalene, 11.86 mg DL-α-tocopherol, and 4.86 mg polysorbate 80). Each 0.5-mL dose may also contain residual amounts of ovalbumin (≤0.083 mcg), formaldehyde (≤12.5 mcg), and sodium deoxycholate (≤3.75 mcg) from the manufacturing process. Each 0.25‑mL dose of AREPANRIX (H5N8) for individuals 6 months through 17 years contains 1.9 mcg hemagglutinin (HA) of the influenza virus strain A/Astrakhan/3212/2020-like (H5N8, clade 2.3.4.4b); 2.5 mcg thimerosal, a mercury derivative, as a preservative (1.25 mcg mercury); and AS03 adjuvant (5.35 mg squalene, 5.93 mg DL-α-tocopherol, and 2.43 mg polysorbate 80). Each 0.25‑mL dose may also contain residual amounts of ovalbumin (≤0.042 mcg), formaldehyde (≤6.25 mcg), and sodium deoxycholate (≤1.88 mcg) from the manufacturing process. The vial stoppers are not made with natural rubber latex."
},
{
"NDCCode": "58160-821-34",
"PackageDescription": "1 SYRINGE in 1 CARTON (58160-821-34) / 1 mL in 1 SYRINGE (58160-821-05) ",
"NDC11Code": "58160-0821-34",
"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": "Deprecated",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"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 suspension of noninfectious HBsAg for intramuscular administration. 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": "58160-882-12",
"PackageDescription": "1 KIT in 1 CARTON (58160-882-12) * .5 mL in 1 VIAL (58160-719-03) * .5 mL in 1 SYRINGE (58160-749-07) ",
"NDC11Code": "58160-0882-12",
"ProductNDC": "58160-882",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Arexvy",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted",
"DosageFormName": "KIT",
"StartMarketingDate": "20260430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125775",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex."
},
{
"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": "58160-894-15",
"PackageDescription": "1 KIT in 1 CARTON (58160-894-15) * .5 mL in 1 VIAL (58160-719-03) * .5 mL in 1 SYRINGE (58160-749-07) ",
"NDC11Code": "58160-0894-15",
"ProductNDC": "58160-894",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Arexvy",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted",
"DosageFormName": "KIT",
"StartMarketingDate": "20260430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125775",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex."
},
{
"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."
},
{
"NDCCode": "58160-964-12",
"PackageDescription": "1 KIT in 1 CARTON (58160-964-12) * 1 mL in 1 VIAL, GLASS (58160-966-01) * 1 mL in 1 SYRINGE (58160-967-02) ",
"NDC11Code": "58160-0964-12",
"ProductNDC": "58160-964",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Rabavert",
"NonProprietaryName": "Rabies Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20161219",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103334",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161219",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually an immunization series is initiated and completed with 1 vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV.4,11.",
"Description": "RabAvert Rabies Vaccine produced by GlaxoSmithKline GmbH is a sterile, freeze-dried vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The strain Flury LEP was obtained from American Type Culture Collection as the 59th egg passage. The growth medium for propagation of the virus is a synthetic cell culture medium with the addition of human albumin, polygeline (processed bovine gelatin), and antibiotics. The virus is inactivated with β-propiolactone and further processed by zonal centrifugation in a sucrose density gradient. The vaccine is lyophilized after addition of a stabilizer solution that consists of buffered polygeline and potassium glutamate. One dose of reconstituted vaccine contains ≤12 mg polygeline (processed bovine gelatin), ≤0.3 mg human serum albumin, 1 mg potassium glutamate, and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia, and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumin content is ≤3 ng/dose (1 mL), based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin B) added during cell and virus propagation are largely removed during subsequent steps in the manufacturing process. In the final vaccine, neomycin is present at ≤10 mcg, chlortetracycline at ≤200 ng, and amphotericin B at ≤20 ng per dose. RabAvert is intended for intramuscular (IM) injection. The vaccine contains no preservative and should be used immediately after reconstitution with the supplied Sterile Diluent for RabAvert (Water for Injection). The potency of the final product is determined by the National Institutes of Health (NIH) mouse potency test using the United States (US) reference standard. The potency of 1 dose (1.0 mL) of RabAvert is at least 2.5 IU of rabies antigen. RabAvert is a white, freeze-dried vaccine for reconstitution with the diluent prior to use; the reconstituted vaccine is a clear to slightly opalescent, colorless to slightly pink suspension."
},
{
"NDCCode": "0088-2500-33",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0088-2500-33) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00088-2500-33",
"ProductNDC": "0088-2500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apidra",
"NonProprietaryName": "Insulin Glulisine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20090224",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021629",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "INSULIN GLULISINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090224",
"SamplePackage": "N",
"IndicationAndUsage": "APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa. APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide."
},
{
"NDCCode": "0088-2500-34",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0088-2500-34) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00088-2500-34",
"ProductNDC": "0088-2500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apidra",
"NonProprietaryName": "Insulin Glulisine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20090224",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021629",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "INSULIN GLULISINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090224",
"SamplePackage": "N",
"IndicationAndUsage": "APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa. APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide."
},
{
"NDCCode": "0088-2502-01",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (0088-2502-01) / 3 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00088-2502-01",
"ProductNDC": "0088-2502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apidra Solostar",
"NonProprietaryName": "Insulin Glulisine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20090224",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021629",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "INSULIN GLULISINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090224",
"SamplePackage": "N",
"IndicationAndUsage": "APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa. APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide."
},
{
"NDCCode": "0088-2502-05",
"PackageDescription": "5 SYRINGE, PLASTIC in 1 CARTON (0088-2502-05) / 3 mL in 1 SYRINGE, PLASTIC (0088-2502-00) ",
"NDC11Code": "00088-2502-05",
"ProductNDC": "0088-2502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apidra Solostar",
"NonProprietaryName": "Insulin Glulisine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20090224",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021629",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "INSULIN GLULISINE",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090224",
"SamplePackage": "N",
"IndicationAndUsage": "APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa. APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58160-823-11</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-823-11) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03) </PackageDescription>
<NDC11Code>58160-0823-11</NDC11Code>
<ProductNDC>58160-823</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Shingrix</ProprietaryName>
<NonProprietaryName>Zoster Vaccine Recombinant, Adjuvanted</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171020</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125614</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>49884-823-11</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-823-11) </PackageDescription>
<NDC11Code>49884-0823-11</NDC11Code>
<ProductNDC>49884-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120628</StartMarketingDate>
<EndMarketingDate>20190228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078783</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120628</StartMarketingDatePackage>
<EndMarketingDatePackage>20190228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50268-823-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-823-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-823-11) </PackageDescription>
<NDC11Code>50268-0823-15</NDC11Code>
<ProductNDC>50268-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077670</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 112.0 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Ascorbic acid (in 25 mg, 50 mg and 100 mg tablets), D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance.</Description>
</NDC>
<NDC>
<NDCCode>60687-823-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (60687-823-01) / 1 TABLET in 1 BLISTER PACK (60687-823-11) </PackageDescription>
<NDC11Code>60687-0823-01</NDC11Code>
<ProductNDC>60687-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078888</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. .</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet).</Description>
</NDC>
<NDC>
<NDCCode>68084-823-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-823-21) / 1 TABLET in 1 BLISTER PACK (68084-823-11) </PackageDescription>
<NDC11Code>68084-0823-21</NDC11Code>
<ProductNDC>68084-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040300</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a CNS stimulant. They are available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc. Note: Methylphenidate hydrochloride tablets are color-additive free.</Description>
</NDC>
<NDC>
<NDCCode>58160-801-11</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-801-11) * 10 VIAL in 1 CARTON (58160-809-05) > .5 mL in 1 VIAL (58160-809-01)</PackageDescription>
<NDC11Code>58160-0801-11</NDC11Code>
<ProductNDC>58160-801</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Menhibrix</ProprietaryName>
<NonProprietaryName>Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130903</StartMarketingDate>
<EndMarketingDate>20170917</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125363</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>58160-810-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-810-11) > .5 mL in 1 VIAL (58160-810-01) </PackageDescription>
<NDC11Code>58160-0810-11</NDC11Code>
<ProductNDC>58160-810</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Infanrix</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20090724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103647</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>25; 8; 25; 10; 25</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-812-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-812-11) > .5 mL in 1 VIAL (58160-812-01) </PackageDescription>
<NDC11Code>58160-0812-11</NDC11Code>
<ProductNDC>58160-812</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Kinrix</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20080709</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125260</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>25; 8; 25; 10; 25; 40; 8; 32</StrengthNumber>
<StrengthUnit>[iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-815-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-815-11) > 1 mL in 1 VIAL (58160-815-01)</PackageDescription>
<NDC11Code>58160-0815-11</NDC11Code>
<ProductNDC>58160-815</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Twinrix</ProprietaryName>
<NonProprietaryName>Hepatitis A And Hepatitis B (recombinant) Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20070607</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103850</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
<StrengthNumber>720; 20</StrengthNumber>
<StrengthUnit>[iU]/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-12</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58160-818-11</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-818-11) * 10 VIAL in 1 CARTON (58160-816-05) / .5 mL in 1 VIAL (58160-816-01) * 10 VIAL in 1 PACKAGE (58160-817-05) / .85 mL in 1 VIAL (58160-817-01) </PackageDescription>
<NDC11Code>58160-0818-11</NDC11Code>
<ProductNDC>58160-818</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Hiberix</ProprietaryName>
<NonProprietaryName>Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125347</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).</IndicationAndUsage>
<Description>HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a solution for intramuscular injection, supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. HIBERIX contains Haemophilus b capsular polysaccharide (polyribosyl‑ribitol‑phosphate [PRP]), a high molecular weight polymer prepared from the H. influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi‑synthetic medium, is detoxified with formaldehyde and purified. The capsular polysaccharide is covalently bound to the tetanus toxoid. After purification, the conjugate is lyophilized in the presence of lactose as a stabilizer. The diluent for HIBERIX is a sterile saline solution (0.9% sodium chloride) supplied in prefilled syringes. After reconstitution, each approximately 0.5‑mL dose of HIBERIX contains 10 mcg of purified capsular polysaccharide conjugated to approximately 25 mcg of tetanus toxoid, 12.6 mg of lactose, and ≤0.5 mcg of residual formaldehyde. HIBERIX does not contain a preservative. The stopper of the vial containing Lyophilized Antigen Component and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>58160-820-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-820-11) > .5 mL in 1 VIAL (58160-820-01) </PackageDescription>
<NDC11Code>58160-0820-11</NDC11Code>
<ProductNDC>58160-820</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Engerix-b</ProprietaryName>
<NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20070425</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103239</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-821-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-821-11) / 1 mL in 1 VIAL (58160-821-01) </PackageDescription>
<NDC11Code>58160-0821-11</NDC11Code>
<ProductNDC>58160-821</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Engerix-b</ProprietaryName>
<NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20070328</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103239</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>58160-825-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-825-11) > .5 mL in 1 VIAL (58160-825-01) </PackageDescription>
<NDC11Code>58160-0825-11</NDC11Code>
<ProductNDC>58160-825</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Havrix</ProprietaryName>
<NonProprietaryName>Hepatitis A Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20070216</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103475</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>720</StrengthNumber>
<StrengthUnit>[iU]/.5mL</StrengthUnit>
<Pharm_Classes>Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [CS],Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-826-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-826-11) > 1 mL in 1 VIAL (58160-826-01) </PackageDescription>
<NDC11Code>58160-0826-11</NDC11Code>
<ProductNDC>58160-826</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Havrix</ProprietaryName>
<NonProprietaryName>Hepatitis A Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20070413</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103475</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>1440</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [CS],Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-842-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-842-11) / .5 mL in 1 VIAL (58160-842-01) </PackageDescription>
<NDC11Code>58160-0842-11</NDC11Code>
<ProductNDC>58160-842</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Boostrix</ProprietaryName>
<NonProprietaryName>Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20090724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125106</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<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)</SubstanceName>
<StrengthNumber>8; 2.5; 8; 5; 2.5</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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 vials 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. BOOSTRIX is formulated without preservatives.</Description>
</NDC>
<NDC>
<NDCCode>58160-848-11</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-848-11) * .5 mL in 1 VIAL (58160-723-03) * .5 mL in 1 VIAL (58160-744-03) </PackageDescription>
<NDC11Code>58160-0848-11</NDC11Code>
<ProductNDC>58160-848</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Arexvy</ProprietaryName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230503</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125775</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>50090-3096-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-3096-0) * 1 mL in 1 VIAL, GLASS (58160-966-01) * 1 mL in 1 SYRINGE (58160-967-02) </PackageDescription>
<NDC11Code>50090-3096-00</NDC11Code>
<ProductNDC>50090-3096</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Rabavert</ProprietaryName>
<NonProprietaryName>Rabies Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161219</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103334</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually an immunization series is initiated and completed with 1 vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV.4,11.</IndicationAndUsage>
<Description>RabAvert Rabies Vaccine produced by GlaxoSmithKline GmbH is a sterile, freeze-dried vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The strain Flury LEP was obtained from American Type Culture Collection as the 59th egg passage. The growth medium for propagation of the virus is a synthetic cell culture medium with the addition of human albumin, polygeline (processed bovine gelatin), and antibiotics. The virus is inactivated with β-propiolactone and further processed by zonal centrifugation in a sucrose density gradient. The vaccine is lyophilized after addition of a stabilizer solution that consists of buffered polygeline and potassium glutamate. One dose of reconstituted vaccine contains ≤12 mg polygeline (processed bovine gelatin), ≤0.3 mg human serum albumin, 1 mg potassium glutamate, and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia, and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumin content is ≤3 ng/dose (1 mL), based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin B) added during cell and virus propagation are largely removed during subsequent steps in the manufacturing process. In the final vaccine, neomycin is present at ≤10 mcg, chlortetracycline at ≤200 ng, and amphotericin B at ≤20 ng per dose. RabAvert is intended for intramuscular (IM) injection. The vaccine contains no preservative and should be used immediately after reconstitution with the supplied Sterile Diluent for RabAvert (Water for Injection). The potency of the final product is determined by the National Institutes of Health (NIH) mouse potency test using the United States (US) reference standard. The potency of 1 dose (1.0 mL) of RabAvert is at least 2.5 IU of rabies antigen. RabAvert is a white, freeze-dried vaccine for reconstitution with the diluent prior to use; the reconstituted vaccine is a clear to slightly opalescent, colorless to slightly pink suspension.</Description>
</NDC>
<NDC>
<NDCCode>58160-725-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-725-52) / .5 mL in 1 SYRINGE (58160-725-41) </PackageDescription>
<NDC11Code>58160-0725-52</NDC11Code>
<ProductNDC>58160-725</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix</ProprietaryName>
<ProprietaryNameSuffix>2026/2027</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<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)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>58160-742-25</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-742-25) * 10 VIAL in 1 CARTON (58160-753-19) / 2.5 mL in 1 VIAL (58160-753-01) * 10 VIAL in 1 CARTON (58160-855-19) / 2.5 mL in 1 VIAL (58160-855-01) </PackageDescription>
<NDC11Code>58160-0742-25</NDC11Code>
<ProductNDC>58160-742</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Arepanrix</ProprietaryName>
<NonProprietaryName>Influenza A H5 Monovalent Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260511</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125419</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AREPANRIX is indicated for active immunization for the prevention of disease caused by the influenza A virus H5 subtype contained in the vaccine. AREPANRIX is approved for use in individuals 6 months of age and older at increased risk of exposure to the influenza A virus H5 subtype contained in the vaccine. In individuals 6 months through 17 years of age, this indication is approved under accelerated approval based on immune responses, as measured by hemagglutination‑inhibition (HI) titers [see Clinical Studies (14.2)]. Continued approval for this indication in individuals 6 months through 17 years of age may be contingent upon verification and description of clinical benefit in a confirmatory trial.</IndicationAndUsage>
<Description>AREPANRIX (Influenza A [H5] Monovalent Vaccine, Adjuvanted) is a sterile injectable emulsion administered intramuscularly. The vaccine is supplied as 2 components: a vial of inactivated, split-virion, H5 Antigen Component and a vial of AS03 Adjuvant Component that must be combined prior to administration to form AREPANRIX. The H5 Antigen Component is manufactured according to a similar process as that used to produce the antigens contained in FLULAVAL (Influenza Vaccine) and FLULAVAL QUADRIVALENT (Influenza Vaccine), which are unadjuvanted seasonal influenza vaccines licensed in the U.S. The H5 Antigen Component is a sterile, translucent to whitish opalescent suspension in a phosphate-buffered, thimerosal‑containing saline solution that may sediment slightly. The sediment resuspends upon mixing by inversion to form a homogeneous suspension. The H5 Antigen Component is prepared from virus propagated in the allantoic cavity of embryonated hen’s eggs. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate. The AS03 Adjuvant Component is a homogenized, sterile, whitish to yellowish milky emulsion composed of squalene, DL-α-tocopherol, and polysorbate 80. AREPANRIX is prepared by combining the H5 Antigen Component with the AS03 Adjuvant Component. After combining, AREPANRIX is a whitish to yellowish homogenous milky emulsion. Each 0.5‑mL dose of AREPANRIX (H5N8) for individuals 18 years of age and older contains 3.75 mcg hemagglutinin (HA) of the influenza virus strain A/Astrakhan/3212/2020-like (H5N8, clade 2.3.4.4b); 5 mcg thimerosal, a mercury derivative, as a preservative (2.5 mcg mercury); and AS03 adjuvant (10.69 mg squalene, 11.86 mg DL-α-tocopherol, and 4.86 mg polysorbate 80). Each 0.5-mL dose may also contain residual amounts of ovalbumin (≤0.083 mcg), formaldehyde (≤12.5 mcg), and sodium deoxycholate (≤3.75 mcg) from the manufacturing process. Each 0.25‑mL dose of AREPANRIX (H5N8) for individuals 6 months through 17 years contains 1.9 mcg hemagglutinin (HA) of the influenza virus strain A/Astrakhan/3212/2020-like (H5N8, clade 2.3.4.4b); 2.5 mcg thimerosal, a mercury derivative, as a preservative (1.25 mcg mercury); and AS03 adjuvant (5.35 mg squalene, 5.93 mg DL-α-tocopherol, and 2.43 mg polysorbate 80). Each 0.25‑mL dose may also contain residual amounts of ovalbumin (≤0.042 mcg), formaldehyde (≤6.25 mcg), and sodium deoxycholate (≤1.88 mcg) from the manufacturing process. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>58160-821-34</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (58160-821-34) / 1 mL in 1 SYRINGE (58160-821-05) </PackageDescription>
<NDC11Code>58160-0821-34</NDC11Code>
<ProductNDC>58160-821</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Engerix-b</ProprietaryName>
<NonProprietaryName>Hepatitis B Vaccine (recombinant)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20070328</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103239</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.</IndicationAndUsage>
<Description>ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a sterile suspension of noninfectious HBsAg for intramuscular administration. 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.</Description>
</NDC>
<NDC>
<NDCCode>58160-882-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-882-12) * .5 mL in 1 VIAL (58160-719-03) * .5 mL in 1 SYRINGE (58160-749-07) </PackageDescription>
<NDC11Code>58160-0882-12</NDC11Code>
<ProductNDC>58160-882</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Arexvy</ProprietaryName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125775</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>58160-884-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-884-52) / .5 mL in 1 SYRINGE (58160-884-41) </PackageDescription>
<NDC11Code>58160-0884-52</NDC11Code>
<ProductNDC>58160-884</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix</ProprietaryName>
<ProprietaryNameSuffix>2024/2025</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<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)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>58160-894-15</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-894-15) * .5 mL in 1 VIAL (58160-719-03) * .5 mL in 1 SYRINGE (58160-749-07) </PackageDescription>
<NDC11Code>58160-0894-15</NDC11Code>
<ProductNDC>58160-894</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Arexvy</ProprietaryName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125775</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: 1 individuals 60 years of age and older;, 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre‑fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial or prefilled syringe of AS01E adjuvant as the Adjuvant Suspension Component. The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal‑derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. The AS01E adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS‑21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution of the vial and vial presentation, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. After reconstitution of the vial and prefilled syringe presentation, each dose (approximately 0.5 mL) is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS‑21. Each dose also contains 16.3 mg of Trehalose, 4.4 mg of sodium chloride, 0.87 mg of potassium dihydrogen phosphate, 0.29 mg of dipotassium phosphate, 0.20 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY contains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process. The stopper of the vial containing Lyophilized Antigen Component or Adjuvant Suspension Component and the tip cap and plunger stopper of the prefilled syringe containing Adjuvant Suspension Component are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>58160-909-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-909-52) / .5 mL in 1 SYRINGE (58160-909-41) </PackageDescription>
<NDC11Code>58160-0909-52</NDC11Code>
<ProductNDC>58160-909</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2023/2024</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20230630</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<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)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230630</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>58160-912-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-912-52) / .5 mL in 1 SYRINGE (58160-912-41) </PackageDescription>
<NDC11Code>58160-0912-52</NDC11Code>
<ProductNDC>58160-912</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix</ProprietaryName>
<ProprietaryNameSuffix>2025/2026</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<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)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>58160-964-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-964-12) * 1 mL in 1 VIAL, GLASS (58160-966-01) * 1 mL in 1 SYRINGE (58160-967-02) </PackageDescription>
<NDC11Code>58160-0964-12</NDC11Code>
<ProductNDC>58160-964</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Rabavert</ProprietaryName>
<NonProprietaryName>Rabies Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161219</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103334</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161219</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually an immunization series is initiated and completed with 1 vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV.4,11.</IndicationAndUsage>
<Description>RabAvert Rabies Vaccine produced by GlaxoSmithKline GmbH is a sterile, freeze-dried vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The strain Flury LEP was obtained from American Type Culture Collection as the 59th egg passage. The growth medium for propagation of the virus is a synthetic cell culture medium with the addition of human albumin, polygeline (processed bovine gelatin), and antibiotics. The virus is inactivated with β-propiolactone and further processed by zonal centrifugation in a sucrose density gradient. The vaccine is lyophilized after addition of a stabilizer solution that consists of buffered polygeline and potassium glutamate. One dose of reconstituted vaccine contains ≤12 mg polygeline (processed bovine gelatin), ≤0.3 mg human serum albumin, 1 mg potassium glutamate, and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia, and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumin content is ≤3 ng/dose (1 mL), based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin B) added during cell and virus propagation are largely removed during subsequent steps in the manufacturing process. In the final vaccine, neomycin is present at ≤10 mcg, chlortetracycline at ≤200 ng, and amphotericin B at ≤20 ng per dose. RabAvert is intended for intramuscular (IM) injection. The vaccine contains no preservative and should be used immediately after reconstitution with the supplied Sterile Diluent for RabAvert (Water for Injection). The potency of the final product is determined by the National Institutes of Health (NIH) mouse potency test using the United States (US) reference standard. The potency of 1 dose (1.0 mL) of RabAvert is at least 2.5 IU of rabies antigen. RabAvert is a white, freeze-dried vaccine for reconstitution with the diluent prior to use; the reconstituted vaccine is a clear to slightly opalescent, colorless to slightly pink suspension.</Description>
</NDC>
<NDC>
<NDCCode>0088-2500-33</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0088-2500-33) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00088-2500-33</NDC11Code>
<ProductNDC>0088-2500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apidra</ProprietaryName>
<NonProprietaryName>Insulin Glulisine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20090224</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021629</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLULISINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa. APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0088-2500-34</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0088-2500-34) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00088-2500-34</NDC11Code>
<ProductNDC>0088-2500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apidra</ProprietaryName>
<NonProprietaryName>Insulin Glulisine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20090224</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021629</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLULISINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa. APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0088-2502-01</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (0088-2502-01) / 3 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00088-2502-01</NDC11Code>
<ProductNDC>0088-2502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apidra Solostar</ProprietaryName>
<NonProprietaryName>Insulin Glulisine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20090224</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021629</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLULISINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa. APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0088-2502-05</NDCCode>
<PackageDescription>5 SYRINGE, PLASTIC in 1 CARTON (0088-2502-05) / 3 mL in 1 SYRINGE, PLASTIC (0088-2502-00) </PackageDescription>
<NDC11Code>00088-2502-05</NDC11Code>
<ProductNDC>0088-2502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apidra Solostar</ProprietaryName>
<NonProprietaryName>Insulin Glulisine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20090224</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021629</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLULISINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glulisine is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. Insulin glulisine has a molecular weight of 5.823 kDa. APIDRA (insulin glulisine) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each milliliter of APIDRA contains 100 units insulin glulisine, metacresol (3.15 mg), polysorbate 20 (0.01 mg), sodium chloride (5 mg), tromethamine (6 mg), and water for injection. APIDRA has a pH of approximately 7.3. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide.</Description>
</NDC>
</NDCList>