Home NDC 63361-243 VAXELIS
Product NDC 63361-243
11-digit product format 633610243
Labeler code 63361
Product ID 63361-243_899b15fd-89c2-44ab-95c8-a457ea7cf0be
Type VACCINE
Nonproprietary name diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler MSP Vaccine Company
Application BLA125563
Marketing category BLA
Marketing start 2018-12-21
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); HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN; HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; 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; 3; 10; 29; 7; 26 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.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], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Haemophilus Vaccines [CS], Hepatitis B Vaccines [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 Haemophilus Influenzae B Vaccine [EPC], Inactivated Hepatitis B Virus 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], 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 VAXELIS
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 HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 3 ug/.5mL HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug/.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 63361-243-15 VAXELIS 10 in 1 PACKAGE INJECTION, SUSPENSION 10 14 63361-243-88 VAXELIS 0.5 mL in 1 SYRINGE INJECTION, SUSPENSION 0.5 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63361-243 VAXELIS (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS, INACTIVATED POLIOVIRUS, HAEMOPHILUS B CONJUGATE AND HEPATITIS B VACCINE) INJECTION, SUSPENSION [MSP VACCINE COMPANY] 10 Current NDC, Legacy NDC, 2 package rows 20221022_3ed8472a-c6eb-4076-9d66-025ede589e3d.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2468237 DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe PSN 3ed8472a-c6eb-4076-9d66-025ede589e3d 14 2468239 Vaxelis 0.5 ML Prefilled Syringe PSN 3ed8472a-c6eb-4076-9d66-025ede589e3d 14 2468239 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 / Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.006 MG/ML / hepatitis B surface antigen vaccine 0.02 MG/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 vac SBD 3ed8472a-c6eb-4076-9d66-025ede589e3d 14 2468237 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 / Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.006 MG/ML / hepatitis B surface antigen vaccine 0.02 MG/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 vac SCD 3ed8472a-c6eb-4076-9d66-025ede589e3d 14 2468237 DTap-IPV-Hib-HepB 0.5 ML Prefilled Syringe SY 3ed8472a-c6eb-4076-9d66-025ede589e3d 14 2468239 Vaxelis (Diphtheria and Tetanus Toxoids and Acelluar Pertussis Absorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine) 0.5 ML Prefilled Syringe SY 3ed8472a-c6eb-4076-9d66-025ede589e3d 14 2468237 DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe PSN 174faf80-eb4f-4f11-b875-d74bd26c2e65 1 2468239 Vaxelis 0.5 ML Prefilled Syringe PSN 174faf80-eb4f-4f11-b875-d74bd26c2e65 1 2468239 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 / Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.006 MG/ML / hepatitis B surface antigen vaccine 0.02 MG/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 vac SBD 174faf80-eb4f-4f11-b875-d74bd26c2e65 1 2468237 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 / Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.006 MG/ML / hepatitis B surface antigen vaccine 0.02 MG/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 vac SCD 174faf80-eb4f-4f11-b875-d74bd26c2e65 1 2468237 DTap-IPV-Hib-HepB 0.5 ML Prefilled Syringe SY 174faf80-eb4f-4f11-b875-d74bd26c2e65 1 2468239 Vaxelis (Diphtheria and Tetanus Toxoids and Acelluar Pertussis Absorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine) 0.5 ML Prefilled Syringe SY 174faf80-eb4f-4f11-b875-d74bd26c2e65 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63361-243-10 63361024310 10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-243-10) > .5 mL in 1 VIAL, SINGLE-DOSE (63361-243-58) 2018-12-21 0000-00-00 No No Current 63361-243-15 63361024315 10 SYRINGE in 1 PACKAGE (63361-243-15) / .5 mL in 1 SYRINGE (63361-243-88) 10 syringe 2018-12-21 0000-00-00 No No Current 63361-243-88 63361024388 0.5 mL in 1 SYRINGE 0.5 ml Historical