"52125-833-01" National Drug Code (NDC)

NDC Code	52125-833-01
Package Description	.5 mL in 1 VIAL, SINGLE-DOSE (52125-833-01)
Product NDC	52125-833
Product Type Name	VACCINE
Proprietary Name	Gardasil
Non-Proprietary Name	Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) Vaccine, Recombinant
Dosage Form	INJECTION, SUSPENSION
Usage	INTRAMUSCULAR
Start Marketing Date	20140213
Marketing Category Name	BLA
Application Number	BLA125126
Manufacturer	REMEDYREPACK INC.
Substance Name	HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN
Strength	40; 20; 40; 20
Strength Unit	ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharmacy Classes	Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]