NDC 50090-2443

GARDASIL 9

Human Papillomavirus 9-valent Vaccine, Recombinant

GARDASIL 9 is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by A-s Medication Solutions. 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; 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.

• Product ID: 50090-2443_ea946e06-0c6d-4735-8718-bf71ca7648d1
• NDC: 50090-2443
• Product Type: Vaccine
• Proprietary Name: GARDASIL 9
• Generic Name: Human Papillomavirus 9-valent Vaccine, Recombinant
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2014-12-10
• Marketing Category: BLA / BLA
• Application Number: BLA125508
• Labeler Name: A-S Medication Solutions
• Substance Name: 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; 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
• Active Ingredient Strength: 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50090-2443-0

10 mL in 1 CARTON (50090-2443-0)

• Marketing Start Date: 2014-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-2443-0 [50090244300]

GARDASIL 9 INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA125508
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2014-12-10
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN	30 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 9" or generic name "Human Papillomavirus 9-valent Vaccine, Recombinant"

NDC	Brand Name	Generic Name
0006-4119	GARDASIL 9	Human Papillomavirus 9-valent Vaccine, Recombinant
0006-4121	GARDASIL 9	Human Papillomavirus 9-valent Vaccine, Recombinant
50090-2443	GARDASIL 9	Human Papillomavirus 9-valent Vaccine, Recombinant