{
"NDC": [
{
"NDCCode": "58160-811-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-811-52) / .5 mL in 1 SYRINGE (58160-811-43) ",
"NDC11Code": "58160-0811-52",
"ProductNDC": "58160-811",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Pediarix",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103907",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "25; 10; 25; 25; 8; 10; 40; 8; 32",
"StrengthUnit": "[iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090724",
"SamplePackage": "N",
"IndicationAndUsage": "PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).",
"Description": "PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 10 mcg of HBsAg, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components are the same as those in INFANRIX and KINRIX. The hepatitis B surface antigen is the same as that in ENGERIX-B. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. The hepatitis B surface antigen is obtained by culturing genetically engineered Saccharomyces cerevisiae (S. cerevisiae) cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic medium. The surface antigen expressed in the S. cerevisiae cells is purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration. The inactivated poliovirus component is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor present an undue risk for BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The hepatitis B component is adsorbed onto aluminum phosphate. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis component (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Potency of the hepatitis B component is established by HBsAg ELISA. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus-neutralizing cell culture assay on sera from previously immunized rats. Each 0.5 mL dose contains aluminum hydroxide and aluminum phosphate as adjuvants (formulated to contain 0.7 mg aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The procedures used to manufacture the HBsAg antigen result in a product that contains ≤5% yeast protein. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. PEDIARIX is formulated without preservatives."
},
{
"NDCCode": "58160-725-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-725-52) / .5 mL in 1 SYRINGE (58160-725-41) ",
"NDC11Code": "58160-0725-52",
"ProductNDC": "58160-725",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluarix",
"ProprietaryNameSuffix": "2026/2027",
"NonProprietaryName": "Influenza Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20260701",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125127",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20260701",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "FLUARIX is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see Description (11)]. FLUARIX is approved for use in persons aged 6 months and older.",
"Description": "FLUARIX, Influenza Vaccine, is a sterile colorless and slightly opalescent injectable suspension for intramuscular use. FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus‑containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate‑buffered isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus solutions. FLUARIX is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5‑mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/Switzerland/6849/2025 IVR‑278 (an A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Michigan/105/2025 SAN-049A (an A/Darwin/1454/2025‑like virus) (H3N2), and B/Tokyo/EIS13‑175/2025 (B‑Victoria lineage). These three influenza virus strains are recommended by FDA for the 2026‑2027 influenza season. FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal. Each 0.5‑mL dose also contains octoxinol‑10 (TRITON X‑100) ≤0.085 mg, α‑tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0015 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
},
{
"NDCCode": "58160-810-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-810-52) / .5 mL in 1 SYRINGE (58160-810-43) ",
"NDC11Code": "58160-0810-52",
"ProductNDC": "58160-810",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Infanrix",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103647",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "10; 25; 25; 25; 8",
"StrengthUnit": "[iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090724",
"SamplePackage": "N",
"IndicationAndUsage": "INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday).",
"Description": "INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), and 8 mcg of pertactin (69 kiloDalton outer membrane protein). The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and 4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. INFANRIX is formulated without preservatives."
},
{
"NDCCode": "58160-812-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-812-52) / .5 mL in 1 SYRINGE (58160-812-43) ",
"NDC11Code": "58160-0812-52",
"ProductNDC": "58160-812",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Kinrix",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20080709",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125260",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "25; 10; 25; 8; 25; 40; 8; 32",
"StrengthUnit": "[iU]/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080709",
"SamplePackage": "N",
"IndicationAndUsage": "A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.",
"Description": "KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D‑antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF‑1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The inactivated poliovirus component of KINRIX is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus-neutralizing cell culture assay on sera from previously immunized rats. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. KINRIX does not contain a preservative."
},
{
"NDCCode": "58160-815-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-815-52) / 1 mL in 1 SYRINGE (58160-815-43) ",
"NDC11Code": "58160-0815-52",
"ProductNDC": "58160-815",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Twinrix",
"NonProprietaryName": "Hepatitis A And Hepatitis B (recombinant) Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20070607",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103850",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
"StrengthNumber": "720; 20",
"StrengthUnit": "[iU]/mL; ug/mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070607",
"SamplePackage": "N",
"IndicationAndUsage": "TWINRIX is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. TWINRIX is approved for use in persons 18 years of age or older.",
"Description": "TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine containing the antigenic components used in producing HAVRIX (Hepatitis A Vaccine) and ENGERIX‑B [Hepatitis B Vaccine (Recombinant)]. TWINRIX is a sterile, injectable suspension for intramuscular use that contains inactivated hepatitis A virus (strain HM175) and noninfectious HBsAg. The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells, which carry the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation. A 1 mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, sodium chloride, phosphate buffer, polysorbate 20, and Water for Injection. From the manufacturing process, each 1 mL dose of TWINRIX also contains residual formalin (not more than 0.1 mg), MRC-5 cellular proteins (not more than 2.5 mcg), neomycin sulfate (an aminoglycoside antibiotic included in the cell growth media; not more than 20 ng), and yeast protein (no more than 5%). TWINRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. TWINRIX is formulated without preservatives."
},
{
"NDCCode": "58160-820-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-820-52) / .5 mL in 1 SYRINGE (58160-820-43) ",
"NDC11Code": "58160-0820-52",
"ProductNDC": "58160-820",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Engerix-b",
"NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20070425",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103239",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
"StrengthNumber": "10",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070425",
"SamplePackage": "N",
"IndicationAndUsage": "ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.",
"Description": "ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives."
},
{
"NDCCode": "58160-821-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-821-52) / 1 mL in 1 SYRINGE (58160-821-43) ",
"NDC11Code": "58160-0821-52",
"ProductNDC": "58160-821",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Engerix-b",
"NonProprietaryName": "Hepatitis B Vaccine (recombinant)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20070328",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103239",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
"StrengthNumber": "20",
"StrengthUnit": "ug/mL",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070328",
"SamplePackage": "N",
"IndicationAndUsage": "ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.",
"Description": "ENGERIX‑B [Hepatitis B Vaccine (Recombinant)] is a sterile, injectable suspension of noninfectious HBsAg for intramuscular use. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX‑B result in a product that contains no more than 5% yeast protein. Each 0.5 mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1 mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX‑B contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL). ENGERIX‑B is available in vials (adult dose only) and prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. ENGERIX‑B is formulated without preservatives."
},
{
"NDCCode": "58160-825-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-825-52) / .5 mL in 1 SYRINGE (58160-825-43) ",
"NDC11Code": "58160-0825-52",
"ProductNDC": "58160-825",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Havrix",
"NonProprietaryName": "Hepatitis A Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20070216",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103475",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "720",
"StrengthUnit": "[iU]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070216",
"SamplePackage": "N",
"IndicationAndUsage": "HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.",
"Description": "HAVRIX (Hepatitis A Vaccine) is a sterile, injectable suspension of inactivated virus for intramuscular use. The virus (strain HM175) is propagated in MRC‑5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5 mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
},
{
"NDCCode": "58160-826-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-826-52) / 1 mL in 1 SYRINGE (58160-826-43) ",
"NDC11Code": "58160-0826-52",
"ProductNDC": "58160-826",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Havrix",
"NonProprietaryName": "Hepatitis A Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20070413",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103475",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "1440",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070413",
"SamplePackage": "N",
"IndicationAndUsage": "HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.",
"Description": "HAVRIX (Hepatitis A Vaccine) is a sterile, injectable suspension of inactivated virus for intramuscular use. The virus (strain HM175) is propagated in MRC‑5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5 mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex."
},
{
"NDCCode": "58160-830-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-830-52) > .5 mL in 1 SYRINGE (58160-830-43)",
"NDC11Code": "58160-0830-52",
"ProductNDC": "58160-830",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Cervarix",
"NonProprietaryName": "Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20091016",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125259",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN",
"StrengthNumber": "20; 20",
"StrengthUnit": "ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "58160-842-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-842-52) / .5 mL in 1 SYRINGE (58160-842-43) ",
"NDC11Code": "58160-0842-52",
"ProductNDC": "58160-842",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Boostrix",
"NonProprietaryName": "Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125106",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "5; 2.5; 8; 8; 2.5",
"StrengthUnit": "[iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090724",
"SamplePackage": "N",
"IndicationAndUsage": "BOOSTRIX is indicated for: 1 active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older,, 2 immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.",
"Description": "BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, injectable suspension for intramuscular use. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde‑treated FHA and PRN). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and PRN) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; PRN is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and PRN are treated with formaldehyde. Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5 mL dose is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 mcg of inactivated PT, 8 mcg of FHA, and 2.5 mcg of PRN (69 kiloDalton outer membrane protein). Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde‑treated FHA and PRN) is determined by enzyme‑linked immunosorbent assay (ELISA) on sera from previously immunized mice. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.3 mg aluminum) and 4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). BOOSTRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. BOOSTRIX is formulated without preservatives."
},
{
"NDCCode": "58160-849-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-849-52) / .5 mL in 1 SYRINGE (58160-849-43) ",
"NDC11Code": "58160-0849-52",
"ProductNDC": "58160-849",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Shingrix",
"NonProprietaryName": "Zoster Vaccine Recombinant, Adjuvanted",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250716",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125614",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250716",
"SamplePackage": "N",
"IndicationAndUsage": "SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): 1 in adults aged 50 years and older., 2 in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.",
"Description": "SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is a sterile injectable suspension for intramuscular use that contains recombinant varicella zoster virus gE antigen adjuvanted with AS01B. The vial and vial presentation is supplied as a vial of lyophilized recombinant varicella zoster virus surface gE antigen component (Lyophilized gE Antigen Component), which must be reconstituted at the time of use with the accompanying vial of AS01B (Adjuvant Suspension Component) to form SHINGRIX. The SHINGRIX prefilled syringe presentation does not require reconstitution. SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid. The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal‑derived proteins. The gE protein is purified by several chromatographic steps and formulated with excipients. The AS01B adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) derived from Salmonella minnesota and QS‑21, a saponin purified from Quillaja saponaria Molina plant extract, and is combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. Each 0.5‑mL dose is formulated to contain 50 mcg of the recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS‑21. Each dose also contains 20 mg of sucrose, 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate (applicable to prefilled syringe presentation only), 0.160 mg of sodium dihydrogen phosphate anhydrous (applicable to vial and vial presentation only), 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. SHINGRIX does not contain preservatives. Each dose may also contain residual amounts of host cell proteins (≤3.0%) and DNA (≤2.1 picograms) from the manufacturing process. In the vial and vial presentation, the vial stoppers are not made with natural rubber latex. In the prefilled syringe presentation, the tip cap and rubber plunger stopper are not made with natural rubber latex."
},
{
"NDCCode": "58160-854-52",
"PackageDescription": "1 KIT in 1 CARTON (58160-854-52) * 10 VIAL in 1 CARTON (58160-851-10) / 1 mL in 1 VIAL (58160-851-01) * 1 mL in 1 APPLICATOR (58160-853-02) ",
"NDC11Code": "58160-0854-52",
"ProductNDC": "58160-854",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Rotarix",
"NonProprietaryName": "Rotavirus Vaccine, Live, Oral",
"DosageFormName": "KIT",
"StartMarketingDate": "20110113",
"EndMarketingDate": "20250224",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125265",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Deprecated",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110113",
"EndMarketingDatePackage": "20250224",
"SamplePackage": "N",
"IndicationAndUsage": "ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.",
"Description": "ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. There are two formulations of ROTARIX: a reconstituted lyophilized formulation (supplied in a vial and oral dosing applicator presentation) and a liquid formulation (supplied in an oral dosing applicator only presentation). Formulation for the Vial and Oral Dosing Applicator Presentation. After reconstitution of the lyophilized vaccine component, each 1 mL dose of the ROTARIX formulation for the vial and oral dosing applicator presentation contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine component of this ROTARIX formulation contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in this ROTARIX formulation. PCV-1 is not known to cause disease in humans. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral dosing applicator of liquid diluent [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex; the vial stoppers are not made with natural rubber latex. This ROTARIX formulation contains no preservatives. Formulation for the Oral Dosing Applicator Only Presentation. Each 1.5 mL dose of the ROTARIX formulation for the oral dosing applicator only presentation contains at least 106.0 CCID50 of live, attenuated rotavirus. This ROTARIX formulation contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. This ROTARIX formulation contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex. This ROTARIX formulation contains no preservatives."
},
{
"NDCCode": "58160-880-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-880-52) > .5 mL in 1 SYRINGE (58160-880-41)",
"NDC11Code": "58160-0880-52",
"ProductNDC": "58160-880",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluarix",
"ProprietaryNameSuffix": "2013/2014",
"NonProprietaryName": "Influenza Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125127",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2014-07-28"
},
{
"NDCCode": "58160-881-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-881-52) > .5 mL in 1 SYRINGE (58160-881-41)",
"NDC11Code": "58160-0881-52",
"ProductNDC": "58160-881",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluarix",
"ProprietaryNameSuffix": "2014/2015",
"NonProprietaryName": "Influenza Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20140627",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125127",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2015-07-24"
},
{
"NDCCode": "58160-884-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-884-52) / .5 mL in 1 SYRINGE (58160-884-41) ",
"NDC11Code": "58160-0884-52",
"ProductNDC": "58160-884",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluarix",
"ProprietaryNameSuffix": "2024/2025",
"NonProprietaryName": "Influenza Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240701",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125127",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240701",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "FLUARIX is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see Description (11)]. FLUARIX is approved for use in persons aged 6 months and older.",
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"EndMarketingDate": "20200630",
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"ProductNdcExcludeFlag": "N",
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"LabelerName": "GlaxoSmithKline Biologicals SA",
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"ProductNdcExcludeFlag": "N",
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},
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"PackageDescription": "10 SYRINGE in 1 CARTON (58160-900-52) > .5 mL in 1 SYRINGE (58160-900-41)",
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"ProductNDC": "58160-900",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluarix Quadrivalent",
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"NonProprietaryName": "Influenza Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "BLA",
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"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)",
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"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
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},
{
"NDCCode": "58160-901-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-901-52) > .5 mL in 1 SYRINGE (58160-901-41)",
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"ProprietaryName": "Fluarix Quadrivalent",
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"NonProprietaryName": "Influenza Virus Vaccine",
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},
{
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"PackageDescription": "10 SYRINGE in 1 CARTON (58160-903-52) > .5 mL in 1 SYRINGE (58160-903-41)",
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"ProductNDC": "58160-903",
"ProductTypeName": "VACCINE",
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"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "58160-905-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-905-52) > .5 mL in 1 SYRINGE (58160-905-41)",
"NDC11Code": "58160-0905-52",
"ProductNDC": "58160-905",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluarix Quadrivalent",
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"LabelerName": "GlaxoSmithKline Biologicals SA",
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"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "58160-907-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-907-52) > .5 mL in 1 SYRINGE (58160-907-41) ",
"NDC11Code": "58160-0907-52",
"ProductNDC": "58160-907",
"ProductTypeName": "VACCINE",
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"StartMarketingDate": "20170707",
"EndMarketingDate": "20180630",
"MarketingCategoryName": "BLA",
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"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)",
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"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170707",
"EndMarketingDatePackage": "20180630",
"SamplePackage": "N"
},
{
"NDCCode": "58160-909-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-909-52) / .5 mL in 1 SYRINGE (58160-909-41) ",
"NDC11Code": "58160-0909-52",
"ProductNDC": "58160-909",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluarix Quadrivalent",
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"NonProprietaryName": "Influenza Virus Vaccine",
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"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)",
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"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
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},
{
"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": "50090-3372-0",
"PackageDescription": "1 KIT in 1 KIT (50090-3372-0) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03) ",
"NDC11Code": "50090-3372-00",
"ProductNDC": "50090-3372",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Shingrix",
"NonProprietaryName": "Zoster Vaccine Recombinant, Adjuvanted",
"DosageFormName": "KIT",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125614",
"LabelerName": "A-S Medication Solutions",
"Status": "Deprecated",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "N",
"IndicationAndUsage": "SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles). in adults aged 50 years and older. 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. Limitations of Use: 1 SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).",
"Description": "SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is a sterile suspension for intramuscular injection. The vaccine is supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E (gE) antigen component, which must be reconstituted at the time of use with the accompanying vial of AS01B adjuvant suspension component. The lyophilized gE antigen component is presented in the form of a sterile white powder. The AS01B adjuvant suspension component is an opalescent, colorless to pale brownish liquid supplied in vials. 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, formulated with excipients, filled into vials, and lyophilized. The adjuvant suspension component is AS01B which 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 phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution, 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 (as stabilizer), 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, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. After reconstitution, SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid. 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. The vial stoppers are not made with natural rubber latex."
}
]
}
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<NDC>
<NDCCode>58160-811-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-811-52) / .5 mL in 1 SYRINGE (58160-811-43) </PackageDescription>
<NDC11Code>58160-0811-52</NDC11Code>
<ProductNDC>58160-811</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Pediarix</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20090724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103907</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>25; 10; 25; 25; 8; 10; 40; 8; 32</StrengthNumber>
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<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).</IndicationAndUsage>
<Description>PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 10 mcg of HBsAg, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components are the same as those in INFANRIX and KINRIX. The hepatitis B surface antigen is the same as that in ENGERIX-B. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. The hepatitis B surface antigen is obtained by culturing genetically engineered Saccharomyces cerevisiae (S. cerevisiae) cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic medium. The surface antigen expressed in the S. cerevisiae cells is purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration. The inactivated poliovirus component is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor present an undue risk for BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The hepatitis B component is adsorbed onto aluminum phosphate. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis component (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Potency of the hepatitis B component is established by HBsAg ELISA. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus-neutralizing cell culture assay on sera from previously immunized rats. Each 0.5 mL dose contains aluminum hydroxide and aluminum phosphate as adjuvants (formulated to contain 0.7 mg aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The procedures used to manufacture the HBsAg antigen result in a product that contains ≤5% yeast protein. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. PEDIARIX is formulated without preservatives.</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>58160-810-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-810-52) / .5 mL in 1 SYRINGE (58160-810-43) </PackageDescription>
<NDC11Code>58160-0810-52</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>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>10; 25; 25; 25; 8</StrengthNumber>
<StrengthUnit>[iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.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>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday).</IndicationAndUsage>
<Description>INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), and 8 mcg of pertactin (69 kiloDalton outer membrane protein). The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and 4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. INFANRIX is formulated without preservatives.</Description>
</NDC>
<NDC>
<NDCCode>58160-812-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-812-52) / .5 mL in 1 SYRINGE (58160-812-43) </PackageDescription>
<NDC11Code>58160-0812-52</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>CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>25; 10; 25; 8; 25; 40; 8; 32</StrengthNumber>
<StrengthUnit>[iU]/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.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>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.</IndicationAndUsage>
<Description>KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D‑antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF‑1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The inactivated poliovirus component of KINRIX is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus-neutralizing cell culture assay on sera from previously immunized rats. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. KINRIX does not contain a preservative.</Description>
</NDC>
<NDC>
<NDCCode>58160-815-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-815-52) / 1 mL in 1 SYRINGE (58160-815-43) </PackageDescription>
<NDC11Code>58160-0815-52</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>Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TWINRIX is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. TWINRIX is approved for use in persons 18 years of age or older.</IndicationAndUsage>
<Description>TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine containing the antigenic components used in producing HAVRIX (Hepatitis A Vaccine) and ENGERIX‑B [Hepatitis B Vaccine (Recombinant)]. TWINRIX is a sterile, injectable suspension for intramuscular use that contains inactivated hepatitis A virus (strain HM175) and noninfectious HBsAg. The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells, which carry the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation. A 1 mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, sodium chloride, phosphate buffer, polysorbate 20, and Water for Injection. From the manufacturing process, each 1 mL dose of TWINRIX also contains residual formalin (not more than 0.1 mg), MRC-5 cellular proteins (not more than 2.5 mcg), neomycin sulfate (an aminoglycoside antibiotic included in the cell growth media; not more than 20 ng), and yeast protein (no more than 5%). TWINRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. TWINRIX is formulated without preservatives.</Description>
</NDC>
<NDC>
<NDCCode>58160-820-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-820-52) / .5 mL in 1 SYRINGE (58160-820-43) </PackageDescription>
<NDC11Code>58160-0820-52</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>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070425</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>58160-821-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-821-52) / 1 mL in 1 SYRINGE (58160-821-43) </PackageDescription>
<NDC11Code>58160-0821-52</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>58160-825-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-825-52) / .5 mL in 1 SYRINGE (58160-825-43) </PackageDescription>
<NDC11Code>58160-0825-52</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>Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.</IndicationAndUsage>
<Description>HAVRIX (Hepatitis A Vaccine) is a sterile, injectable suspension of inactivated virus for intramuscular use. The virus (strain HM175) is propagated in MRC‑5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5 mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>58160-826-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-826-52) / 1 mL in 1 SYRINGE (58160-826-43) </PackageDescription>
<NDC11Code>58160-0826-52</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>Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.</IndicationAndUsage>
<Description>HAVRIX (Hepatitis A Vaccine) is a sterile, injectable suspension of inactivated virus for intramuscular use. The virus (strain HM175) is propagated in MRC‑5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5 mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. HAVRIX is formulated without preservatives. HAVRIX is available in prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>58160-830-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-830-52) > .5 mL in 1 SYRINGE (58160-830-43)</PackageDescription>
<NDC11Code>58160-0830-52</NDC11Code>
<ProductNDC>58160-830</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Cervarix</ProprietaryName>
<NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20091016</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125259</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>58160-842-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-842-52) / .5 mL in 1 SYRINGE (58160-842-43) </PackageDescription>
<NDC11Code>58160-0842-52</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>5; 2.5; 8; 8; 2.5</StrengthNumber>
<StrengthUnit>[iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.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>Active</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 prefilled syringes. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. BOOSTRIX is formulated without preservatives.</Description>
</NDC>
<NDC>
<NDCCode>58160-849-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-849-52) / .5 mL in 1 SYRINGE (58160-849-43) </PackageDescription>
<NDC11Code>58160-0849-52</NDC11Code>
<ProductNDC>58160-849</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Shingrix</ProprietaryName>
<NonProprietaryName>Zoster Vaccine Recombinant, Adjuvanted</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250716</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125614</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250716</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>58160-854-52</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-854-52) * 10 VIAL in 1 CARTON (58160-851-10) / 1 mL in 1 VIAL (58160-851-01) * 1 mL in 1 APPLICATOR (58160-853-02) </PackageDescription>
<NDC11Code>58160-0854-52</NDC11Code>
<ProductNDC>58160-854</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Rotarix</ProprietaryName>
<NonProprietaryName>Rotavirus Vaccine, Live, Oral</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110113</StartMarketingDate>
<EndMarketingDate>20250224</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125265</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110113</StartMarketingDatePackage>
<EndMarketingDatePackage>20250224</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.</IndicationAndUsage>
<Description>ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus vaccine strain is propagated on Vero cells. There are two formulations of ROTARIX: a reconstituted lyophilized formulation (supplied in a vial and oral dosing applicator presentation) and a liquid formulation (supplied in an oral dosing applicator only presentation). Formulation for the Vial and Oral Dosing Applicator Presentation. After reconstitution of the lyophilized vaccine component, each 1 mL dose of the ROTARIX formulation for the vial and oral dosing applicator presentation contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine component of this ROTARIX formulation contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in this ROTARIX formulation. PCV-1 is not known to cause disease in humans. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral dosing applicator of liquid diluent [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex; the vial stoppers are not made with natural rubber latex. This ROTARIX formulation contains no preservatives. Formulation for the Oral Dosing Applicator Only Presentation. Each 1.5 mL dose of the ROTARIX formulation for the oral dosing applicator only presentation contains at least 106.0 CCID50 of live, attenuated rotavirus. This ROTARIX formulation contains disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sucrose, and sterile water. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium dihydrogen phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, and sodium hydrogenocarbonate. This ROTARIX formulation contains an antacid component (disodium adipate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. This ROTARIX formulation is available in single-dose prefilled oral dosing applicator [see How Supplied/Storage and Handling (16)]. The tip caps of the prefilled oral dosing applicators contain natural rubber latex. This ROTARIX formulation contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>58160-880-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-880-52) > .5 mL in 1 SYRINGE (58160-880-41)</PackageDescription>
<NDC11Code>58160-0880-52</NDC11Code>
<ProductNDC>58160-880</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix</ProprietaryName>
<ProprietaryNameSuffix>2013/2014</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-07-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>58160-881-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-881-52) > .5 mL in 1 SYRINGE (58160-881-41)</PackageDescription>
<NDC11Code>58160-0881-52</NDC11Code>
<ProductNDC>58160-881</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix</ProprietaryName>
<ProprietaryNameSuffix>2014/2015</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20140627</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-07-24</LastUpdate>
</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>58160-885-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-885-52) > .5 mL in 1 SYRINGE (58160-885-41) </PackageDescription>
<NDC11Code>58160-0885-52</NDC11Code>
<ProductNDC>58160-885</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2020/2021</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20200702</StartMarketingDate>
<EndMarketingDate>20210630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 NIB-121 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200702</StartMarketingDatePackage>
<EndMarketingDatePackage>20210630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-887-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-887-52) > .5 mL in 1 SYRINGE (58160-887-41) </PackageDescription>
<NDC11Code>58160-0887-52</NDC11Code>
<ProductNDC>58160-887</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2021/2022</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20210702</StartMarketingDate>
<EndMarketingDate>20220630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210702</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-890-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-890-52) / .5 mL in 1 SYRINGE (58160-890-41) </PackageDescription>
<NDC11Code>58160-0890-52</NDC11Code>
<ProductNDC>58160-890</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2022/2023</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<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/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-896-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-896-52) > .5 mL in 1 SYRINGE (58160-896-41) </PackageDescription>
<NDC11Code>58160-0896-52</NDC11Code>
<ProductNDC>58160-896</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2019/2020</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190702</StartMarketingDate>
<EndMarketingDate>20200630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190702</StartMarketingDatePackage>
<EndMarketingDatePackage>20200630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-898-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-898-52) > .5 mL in 1 SYRINGE (58160-898-41) </PackageDescription>
<NDC11Code>58160-0898-52</NDC11Code>
<ProductNDC>58160-898</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2018/2019</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20180629</StartMarketingDate>
<EndMarketingDate>20190630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180629</StartMarketingDatePackage>
<EndMarketingDatePackage>20190630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-900-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-900-52) > .5 mL in 1 SYRINGE (58160-900-41)</PackageDescription>
<NDC11Code>58160-0900-52</NDC11Code>
<ProductNDC>58160-900</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2013/2014</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-07-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>58160-901-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-901-52) > .5 mL in 1 SYRINGE (58160-901-41)</PackageDescription>
<NDC11Code>58160-0901-52</NDC11Code>
<ProductNDC>58160-901</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2014/2015</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>58160-903-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-903-52) > .5 mL in 1 SYRINGE (58160-903-41)</PackageDescription>
<NDC11Code>58160-0903-52</NDC11Code>
<ProductNDC>58160-903</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2015/2016</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>58160-905-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-905-52) > .5 mL in 1 SYRINGE (58160-905-41)</PackageDescription>
<NDC11Code>58160-0905-52</NDC11Code>
<ProductNDC>58160-905</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2016/2017</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>58160-907-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-907-52) > .5 mL in 1 SYRINGE (58160-907-41) </PackageDescription>
<NDC11Code>58160-0907-52</NDC11Code>
<ProductNDC>58160-907</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2017/2018</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20170707</StartMarketingDate>
<EndMarketingDate>20180630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170707</StartMarketingDatePackage>
<EndMarketingDatePackage>20180630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</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>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>50090-3372-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-3372-0) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03) </PackageDescription>
<NDC11Code>50090-3372-00</NDC11Code>
<ProductNDC>50090-3372</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>A-S Medication Solutions</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles). in adults aged 50 years and older. 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. Limitations of Use: 1 SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).</IndicationAndUsage>
<Description>SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is a sterile suspension for intramuscular injection. The vaccine is supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E (gE) antigen component, which must be reconstituted at the time of use with the accompanying vial of AS01B adjuvant suspension component. The lyophilized gE antigen component is presented in the form of a sterile white powder. The AS01B adjuvant suspension component is an opalescent, colorless to pale brownish liquid supplied in vials. 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, formulated with excipients, filled into vials, and lyophilized. The adjuvant suspension component is AS01B which 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 phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution, 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 (as stabilizer), 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, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. After reconstitution, SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid. 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. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
</NDCList>