Home NDC 0069-0600 PENBRAYA
Product NDC 0069-0600
11-digit product format 000690600
Labeler code 0069
Product ID 0069-0600_fdf1d48b-70ac-4177-8419-0100ee23a085
Type VACCINE
Nonproprietary name meningococcal groups a, b, c, w, and y vaccine
Dosage form KIT
Labeler Pfizer Laboratories Div Pfizer Inc
Application BLA125770
Marketing category BLA
Marketing start 2023-11-27
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PENBRAYA
Listing expiration 2027-12-31 DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0069-0600-01 2025-07-29 C162847 48780-1 3b156c62-2e69-fb37-e063-e6dba90a4e07 These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023 0069-0600-01 2025-07-29 C162847 48780-1 3b156c62-2e69-fb37-e063-e6dba90a4e07 These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023 0069-0600-05 2025-07-29 C162847 48780-1 3b156c62-2e69-fb37-e063-e6dba90a4e07 These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023 0069-0600-05 2025-07-29 C162847 48780-1 3b156c62-2e69-fb37-e063-e6dba90a4e07 These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023 0069-0600-10 2025-07-29 C162847 48780-1 3b156c62-2e69-fb37-e063-e6dba90a4e07 These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023 0069-0600-10 2025-07-29 C162847 48780-1 3b156c62-2e69-fb37-e063-e6dba90a4e07 These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0271-01 PENBRAYA 0.5 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 0.5 mL 5 ug in 0.5mL 10 0069-0332-01 PENBRAYA 0.5 mL in 1 SYRINGE SUSPENSION 0.5 mL 0.06 mg in 0.5mL 10 0069-0600-01 PENBRAYA 1 in 1 CARTON KIT 1 10 0069-0600-05 PENBRAYA 5 in 1 CARTON KIT 5 10 0069-0600-10 PENBRAYA 10 in 1 CARTON KIT 10 10 0069-0600-99 PENBRAYA 1 in 1 KIT KIT 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0600 PENBRAYA (MENINGOCOCCAL GROUPS A, B, C, W, AND Y VACCINE) KIT [PFIZER LABORATORIES DIV PFIZER INC] 7 Current NDC, 6 package rows 20241228_fd5652b6-5ae4-437e-a456-47deaf500794.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125770 PENBRAYA Meningococcal Groups A, B, C, W, and Y Vaccine 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2670559 Meningococcal (Groups A,B,C,Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine 0.5 ML Injection PSN fd5652b6-5ae4-437e-a456-47deaf500794 10 2670566 PENBRAYA vaccine 0.5 ML Injection PSN fd5652b6-5ae4-437e-a456-47deaf500794 10 2670566 0.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup B recombinant LP2086 A05 protein variant antigen 0.12 MG/ML / Neisseria meningitidis serogroup B recombinant LP2086 B01 protein variant antigen 0.12 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML Injection [Penbraya] SBD fd5652b6-5ae4-437e-a456-47deaf500794 10 2670559 0.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup B recombinant LP2086 A05 protein variant antigen 0.12 MG/ML / Neisseria meningitidis serogroup B recombinant LP2086 B01 protein variant antigen 0.12 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML Injection SCD fd5652b6-5ae4-437e-a456-47deaf500794 10 2670559 Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup B recombinant LP2086 A05 protein variant antigen 0.06 MG / Neisseria meningitidis serogroup B recombinant LP2086 B01 protein variant antigen 0.06 MG / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG per 0.5 ML Injection SY fd5652b6-5ae4-437e-a456-47deaf500794 10 2670566 Penbraya (Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup B recombinant LP2086 A05 protein variant antigen 0.06 MG / Neisseria meningitidis serogroup B recombinant LP2086 B01 protein variant antigen 0.06 MG / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG) per 0.5 ML Injection SY fd5652b6-5ae4-437e-a456-47deaf500794 10 2670566 Penbraya Meningococcal (Groups A,B,C,Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine 0.5 ML Injection SY fd5652b6-5ae4-437e-a456-47deaf500794 10
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0069-0271-01 00069027101 0.5 mL in 1 VIAL, GLASS 0.5 ml Historical 0069-0332-01 00069033201 0.5 mL in 1 SYRINGE 0.5 ml Historical 0069-0600-01 00069060001 1 KIT in 1 CARTON (0069-0600-01) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) 1 kit 2023-11-27 No No Current 0069-0600-05 00069060005 5 KIT in 1 CARTON (0069-0600-05) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) 5 kit 2023-11-27 No No Current 0069-0600-10 00069060010 10 KIT in 1 CARTON (0069-0600-10) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) 10 kit 2023-11-27 No No Current 0069-0600-99 00069060099 1 in 1 KIT Historical