Home NDC 49281-564 QUADRACEL
Product NDC 49281-564
11-digit product format 492810564
Labeler code 49281
Product ID 49281-564_b943f360-e126-45d4-af57-3fcb4c68d1b2
Type VACCINE
Nonproprietary name diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler Sanofi Vaccines US Inc.
Application BLA125525
Marketing category BLA
Marketing start 2015-03-24
Substance BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength 20; 5; 3; 20; 5; 15; 29; 7; 26 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base QUADRACEL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 20 ug/.5mL BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug/.5mL BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug/.5mL BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 20 ug/.5mL CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf]/.5mL CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf]/.5mL POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 29 [D'ag'U]/.5mL POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 7 [D'ag'U]/.5mL POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 26 [D'ag'U]/.5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49281-564-10 QUADRACEL 10 in 1 PACKAGE INJECTION, SUSPENSION 10 10 49281-564-15 QUADRACEL 10 in 1 PACKAGE INJECTION, SUSPENSION 10 10 49281-564-58 QUADRACEL 0.5 mL in 1 VIAL, SINGLE-USE INJECTION, SUSPENSION 0.5 10 49281-564-88 QUADRACEL 0.5 mL in 1 SYRINGE INJECTION, SUSPENSION 0.5 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49281-564 QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [SANOFI PASTEUR INC.] 6 Current NDC, Legacy NDC, 4 package rows 20230824_76798bc5-6752-4c02-9f03-68a361eea66b.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2593118 diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus (vIPV) vaccine (DTaP-IPV generic for Quadracel) 0.5 ML Prefilled Syringe PSN 76798bc5-6752-4c02-9f03-68a361eea66b 10 2587054 DTaP-vIPV (generic for Quadracel) 0.5 ML Injection PSN 76798bc5-6752-4c02-9f03-68a361eea66b 10 2587057 Quadracel (with vIPV) vaccine 0.5 ML Injection PSN 76798bc5-6752-4c02-9f03-68a361eea66b 10 2593121 Quadracel (with vIPV) vaccine 0.5 ML Prefilled Syringe PSN 76798bc5-6752-4c02-9f03-68a361eea66b 10 2587057 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.04 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.04 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection [Quadracel] SBD 76798bc5-6752-4c02-9f03-68a361eea66b 10 2593121 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.04 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.04 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Quadracel] SBD 76798bc5-6752-4c02-9f03-68a361eea66b 10 2587054 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.04 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.04 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection SCD 76798bc5-6752-4c02-9f03-68a361eea66b 10 2593118 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.04 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.04 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe SCD 76798bc5-6752-4c02-9f03-68a361eea66b 10 2587054 diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus (vIPV) vaccine (DTaP-IPV generic for Quadracel) 0.5 ML Injection SY 76798bc5-6752-4c02-9f03-68a361eea66b 10 2593121 Quadracel (with vIPV) vaccine 0.5 ML Prefilled Syringe SY 76798bc5-6752-4c02-9f03-68a361eea66b 10
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49281-564-10 49281056410 10 VIAL, SINGLE-USE in 1 PACKAGE (49281-564-10) / .5 mL in 1 VIAL, SINGLE-USE (49281-564-58) 2015-03-24 0000-00-00 No No Current 49281-564-15 49281056415 10 SYRINGE in 1 PACKAGE (49281-564-15) / .5 mL in 1 SYRINGE (49281-564-88) 10 syringe 2015-03-24 0000-00-00 No No Current 49281-564-58 49281056458 0.5 mL in 1 VIAL, SINGLE-USE 0.5 ml Historical 49281-564-88 49281056488 0.5 mL in 1 SYRINGE 0.5 ml Historical