Home NDC 50090-7541 PEDIARIX
Product NDC 50090-7541
11-digit product format 500907541
Labeler code 50090
Product ID 50090-7541_2428a09d-35f0-4444-ba52-f67c8210326f
Type VACCINE
Nonproprietary name Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler A-S Medication Solutions
Application BLA103907
Marketing category BLA
Marketing start 2009-07-24
Substance BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); 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)
Active strength 25; 8; 25; 10; 25; 10; 40; 8; 32 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PEDIARIX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 25 ug/.5mL BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 8 ug/.5mL BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 25 ug/.5mL CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [iU]/.5mL CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10 ug/.5mL POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [iU]/.5mL POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8 [iU]/.5mL POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32 [iU]/.5mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-7541-0 PEDIARIX 10 in 1 CARTON INJECTION, SUSPENSION 10 2 50090-7541-1 PEDIARIX .5 mL in 1 SYRINGE INJECTION, SUSPENSION .5 2
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 829987 DTaP-HepB-IPV 0.5 ML Prefilled Syringe PSN dd047022-e51c-4aa1-bd68-bc23161c3ce3 2 829989 PEDIARIX vaccine 0.5 ML Prefilled Syringe PSN dd047022-e51c-4aa1-bd68-bc23161c3ce3 2 829989 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe [PEDIARIX] SBD dd047022-e51c-4aa1-bd68-bc23161c3ce3 2 829987 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe SCD dd047022-e51c-4aa1-bd68-bc23161c3ce3 2 829987 acellular pertussis vaccine 0.058 MG / diphtheria toxoid vaccine 25 UNT / hepatitis B surface antigen vaccine 0.01 MG / poliovirus vaccine inactivated, type 1 (Mahoney) 40 UNT / poliovirus vaccine inactivated, type 2 (MEF-1) 8 UNT / poliovirus vaccine inactivated, type 3 (Saukett) 32 UNT / tetanus toxoid vaccine 10 UNT per 0.5 ML Prefilled Syringe SY dd047022-e51c-4aa1-bd68-bc23161c3ce3 2 829987 diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B and inactivated poliovirus vaccine (DTaP-HepB-IPV) 0.5 ML Prefilled Syringe SY dd047022-e51c-4aa1-bd68-bc23161c3ce3 2 829987 DTaP-HepB-IPV 0.5 ML Prefilled Syringe SY dd047022-e51c-4aa1-bd68-bc23161c3ce3 2 829989 PEDIARIX DTaP-HepB-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine) 0.5 ML Prefilled Syringe SY dd047022-e51c-4aa1-bd68-bc23161c3ce3 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7541-0 50090754100 10 SYRINGE in 1 CARTON (50090-7541-0) / .5 mL in 1 SYRINGE (50090-7541-1) 10 syringe 2009-07-24 No No Current 50090-7541-1 50090754101 .5 mL in 1 SYRINGE Historical