NDC 0006-4109

GARDASIL

Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) Vaccine, Recombinant

GARDASIL is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Human Papillomavirus Type 6 L1 Capsid Protein Antigen; Human Papillomavirus Type 11 L1 Capsid Protein Antigen; Human Papillomavirus Type 16 L1 Capsid Protein Antigen; Human Papillomavirus Type 18 L1 Capsid Protein Antigen.

Product ID0006-4109_043b0611-44ea-47a2-a05f-6c68592c8a42
NDC0006-4109
Product TypeVaccine
Proprietary NameGARDASIL
Generic NameHuman Papillomavirus Quadrivalent (types 6, 11, 16, And 18) Vaccine, Recombinant
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2006-06-08
Marketing CategoryBLA / BLA
Application NumberBLA125126
Labeler NameMerck Sharp & Dohme Corp.
Substance NameHUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN
Active Ingredient Strength20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharm ClassesInactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0006-4109-02

10 SYRINGE in 1 CARTON (0006-4109-02) > .5 mL in 1 SYRINGE (0006-4109-01)
Marketing Start Date2006-06-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-4109-02 [00006410902]

GARDASIL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125126
Product TypeVACCINE
Billing UnitML
Marketing Start Date2014-03-17

NDC 0006-4109-09 [00006410909]

GARDASIL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125126
Product TypeVACCINE
Billing UnitML
Marketing Start Date2006-06-08

NDC 0006-4109-01 [00006410901]

GARDASIL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125126
Product TypeVACCINE
Billing UnitML
Marketing Start Date2006-06-08

NDC 0006-4109-06 [00006410906]

GARDASIL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125126
Product TypeVACCINE
Marketing Start Date2006-06-08
Marketing End Date2011-05-06

Drug Details

Active Ingredients

IngredientStrength
HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN20 ug/.5mL

Pharmacological Class

  • Inactivated Human Papillomavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Papillomavirus Vaccines [CS]
  • Vaccines
  • Inactivated [CS]
  • Inactivated Human Papillomavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Papillomavirus Vaccines [CS]
  • Vaccines
  • Inactivated [CS]
  • Inactivated Human Papillomavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Papillomavirus Vaccines [CS]
  • Vaccines
  • Inactivated [CS]
  • Inactivated Human Papillomavirus Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Papillomavirus Vaccines [CS]
  • Vaccines
  • Inactivated [CS]

NDC Crossover Matching brand name "GARDASIL" or generic name "Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) Vaccine, Recombinant"

NDCBrand NameGeneric Name
0006-4045GARDASILHuman Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
0006-4109GARDASILHuman Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
50090-1523GARDASILHuman Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

Trademark Results [GARDASIL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GARDASIL
GARDASIL
76563892 3015981 Live/Registered
MERCK SHARP & DOHME CORP.
2003-12-05
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