GARDASIL 9

Product NDC
50090-4958
11-digit product format
500904958
Labeler code
50090
Product ID
50090-4958_9c20bdb4-d253-4287-b794-c1e898b7cdef
Type
VACCINE
Nonproprietary name
Human Papillomavirus 9-valent Vaccine, Recombinant
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
BLA125508
Marketing category
BLA
Marketing start
2014-12-10
Substance
HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN
Active strength
40; 60; 40; 20; 20; 20; 20; 20; 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharmacologic classes
Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Human Papillomavirus Vaccine [EPC], Inactivated Human Papillomavirus Vaccine [EPC], Inactivated Human Papillomavirus Vaccine [EPC], Inactivated Human Papillomavirus Vaccine [EPC], Papillomavirus Vaccines [CS], Papillomavirus Vaccines [CS], Papillomavirus Vaccines [CS], Papillomavirus Vaccines [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

Related Records

Related UNII Ingredients

UNIIPreferred termMatched term
Z845VHQ61PHUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN
6LTE2DNX63HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN
J2D279PEM5HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN
53JIL371NSHUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN
759RAC446CHUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN
68S8VCN34FHUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN
55644W68FDHUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN
94Y15HP7LFHUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN
61746O90DYHUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGENHUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-4958-1500904958011 SYRINGE, GLASS in 1 VIAL (50090-4958-1) / .5 mL in 1 SYRINGE, GLASS (50090-4958-0) 2014-12-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GARDASIL 9A-S Medication Solutions2025-05-15VACCINE LABEL14