FDA.reportPublic FDA data

GARDASIL 9

Product NDC
0006-4119
11-digit product format
000064119
Labeler code
0006
Product ID
0006-4119_307d38ed-0bbd-41d8-8f86-62163e421432
Type
VACCINE
Nonproprietary name
Human Papillomavirus 9-valent Vaccine, Recombinant
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Merck Sharp & Dohme LLC
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

Additional Listing Data#

Finished product
Yes
Brand name base
GARDASIL 9
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN40 ug/.5mL
HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN60 ug/.5mL
HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN40 ug/.5mL
HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN20 ug/.5mL
HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN20 ug/.5mL
HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN20 ug/.5mL
HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN20 ug/.5mL
HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN20 ug/.5mL
HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN30 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4119-01GARDASIL 90.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION0.530
0006-4119-03GARDASIL 910 in 1 CARTONINJECTION, SUSPENSION1030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4119-01ML - Milliliter0006-41191e4011b7-6b53-4d3b-912e-dac30378f18d12015-08-04
0006-4119-03ML - Milliliter0006-4119fc67d627-e611-47c9-920e-daa87f9c7fdf12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Human Papillomavirus Type 11 L1 Capsid Protein AntigenACTIVE INGREDIENTZ845VHQ61PGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 16 L1 Capsid Protein AntigenACTIVE INGREDIENT6LTE2DNX63GARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 18 L1 Capsid Protein AntigenACTIVE INGREDIENTJ2D279PEM5GARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 31 L1 Capsid Protein AntigenACTIVE INGREDIENT53JIL371NSGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 33 L1 Capsid Protein AntigenACTIVE INGREDIENT759RAC446CGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 45 L1 Capsid Protein AntigenACTIVE INGREDIENT68S8VCN34FGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 52 L1 Capsid Protein AntigenACTIVE INGREDIENT55644W68FDGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 58 L1 Capsid Protein AntigenACTIVE INGREDIENT94Y15HP7LFGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 6 L1 Capsid Protein AntigenACTIVE INGREDIENT61746O90DYGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 11 L1 Capsid Protein AntigenACTIVE MOIETYZ845VHQ61PGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 16 L1 Capsid Protein AntigenACTIVE MOIETY6LTE2DNX63GARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 18 L1 Capsid Protein AntigenACTIVE MOIETYJ2D279PEM5GARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 31 L1 Capsid Protein AntigenACTIVE MOIETY53JIL371NSGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 33 L1 Capsid Protein AntigenACTIVE MOIETY759RAC446CGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 45 L1 Capsid Protein AntigenACTIVE MOIETY68S8VCN34FGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 52 L1 Capsid Protein AntigenACTIVE MOIETY55644W68FDGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 58 L1 Capsid Protein AntigenACTIVE MOIETY94Y15HP7LFGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
Human Papillomavirus Type 6 L1 Capsid Protein AntigenACTIVE MOIETY61746O90DYGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
HISTIDINEINACTIVE INGREDIENT4QD397987EGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5
WATERINACTIVE INGREDIENT059QF0KO0RGARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4119GARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]29Current NDC, Legacy NDC, 2 package rows20250410_a21f4f4b-b891-4f25-b747-cb9ec7d865d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597099GARDASIL 9 0.5 ML InjectionPSNa21f4f4b-b891-4f25-b747-cb9ec7d865d630
1597103Gardasil 9 0.5 ML Prefilled SyringePSNa21f4f4b-b891-4f25-b747-cb9ec7d865d630
1597094human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 mL InjectionPSNa21f4f4b-b891-4f25-b747-cb9ec7d865d630
1597101human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 mL Prefilled SyringePSNa21f4f4b-b891-4f25-b747-cb9ec7d865d630
15970990.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 33 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 45 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 52 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 58 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.06 MG/ML Injection [Gardasil 9]SBDa21f4f4b-b891-4f25-b747-cb9ec7d865d630
15971030.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 33 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 45 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 52 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 58 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.06 MG/ML Prefilled Syringe [Gardasil 9]SBDa21f4f4b-b891-4f25-b747-cb9ec7d865d630
15970940.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 33 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 45 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 52 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 58 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.06 MG/ML InjectionSCDa21f4f4b-b891-4f25-b747-cb9ec7d865d630
15971010.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 33 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 45 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 52 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 58 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.06 MG/ML Prefilled SyringeSCDa21f4f4b-b891-4f25-b747-cb9ec7d865d630
1597099Gardasil 9, Human Papillomavirus 9-valent (Types 6,11,16,18,31,33,45,52,58) Vaccine, Recombinant 0.5 ML InjectionSYa21f4f4b-b891-4f25-b747-cb9ec7d865d630
1597103Gardasil 9, human Papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 ML Prefilled SyringeSYa21f4f4b-b891-4f25-b747-cb9ec7d865d630
1597094human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 ML InjectionSYa21f4f4b-b891-4f25-b747-cb9ec7d865d630
1597101human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 ML Prefilled SyringeSYa21f4f4b-b891-4f25-b747-cb9ec7d865d630
1597099GARDASIL 9 0.5 ML InjectionPSN8355d971-d377-4d1d-973e-a65798bce7f914
1597094human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 mL InjectionPSN8355d971-d377-4d1d-973e-a65798bce7f914
15970990.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 33 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 45 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 52 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 58 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.06 MG/ML Injection [Gardasil 9]SBD8355d971-d377-4d1d-973e-a65798bce7f914
15970940.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 33 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 45 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 52 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 58 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.06 MG/ML InjectionSCD8355d971-d377-4d1d-973e-a65798bce7f914
1597099Gardasil 9, Human Papillomavirus 9-valent (Types 6,11,16,18,31,33,45,52,58) Vaccine, Recombinant 0.5 ML InjectionSY8355d971-d377-4d1d-973e-a65798bce7f914
1597094human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 ML InjectionSY8355d971-d377-4d1d-973e-a65798bce7f914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-4119-01000064119010.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
0006-4119-030000641190310 VIAL, SINGLE-DOSE in 1 CARTON (0006-4119-03) / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4119-01) 2014-12-100000-00-00NoNoCurrent