Home NDC 0006-4045 GARDASIL
Product NDC 0006-4045
11-digit product format 000064045
Labeler code 0006
Product ID 0006-4045_32651aaa-4a24-4e44-8d7f-9960705a382f
Type VACCINE
Nonproprietary name Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler Merck Sharp & Dohme LLC
Application BLA125126
Marketing category BLA
Marketing start 2006-06-08
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 6 L1 CAPSID PROTEIN ANTIGEN
Active strength 40; 40; 20; 20 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-4045-00 GARDASIL 1 in 1 CARTON INJECTION, SUSPENSION 1 32 0006-4045-01 GARDASIL 0.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION 0.5 32 0006-4045-41 GARDASIL 10 in 1 CARTON INJECTION, SUSPENSION 10 32
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN ACTIVE INGREDIENT Z845VHQ61P GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN ACTIVE INGREDIENT 6LTE2DNX63 GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN ACTIVE INGREDIENT J2D279PEM5 GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN ACTIVE INGREDIENT 61746O90DY GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN ACTIVE MOIETY Z845VHQ61P GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN ACTIVE MOIETY 6LTE2DNX63 GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN ACTIVE MOIETY J2D279PEM5 GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN ACTIVE MOIETY 61746O90DY GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 HISTIDINE INACTIVE INGREDIENT 4QD397987E GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23 WATER INACTIVE INGREDIENT 059QF0KO0R GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.] 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-4045 GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC] 32 Current NDC, Legacy NDC, 3 package rows 20250416_30952400-0572-4431-9150-3a41affffb9a.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 798278 GARDASIL 0.5 ML Prefilled Syringe PSN 30952400-0572-4431-9150-3a41affffb9a 32 798276 human papillomavirus quadrivalent (types 6,11,16,18) vaccine, recombinant 0.5 mL Prefilled Syringe PSN 30952400-0572-4431-9150-3a41affffb9a 32 798278 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.04 MG/ML Prefilled Syringe [Gardasil] SBD 30952400-0572-4431-9150-3a41affffb9a 32 798276 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.04 MG/ML Prefilled Syringe SCD 30952400-0572-4431-9150-3a41affffb9a 32 798278 Gardasil, Human Papillomavirus Quadrivalent (Types 6,11,16,18) Vaccine, Recombinant 0.5 ML Prefilled Syringe SY 30952400-0572-4431-9150-3a41affffb9a 32 798276 human papillomavirus quadrivalent (types 6,11,16,18) vaccine, recombinant 0.5 ML Prefilled Syringe SY 30952400-0572-4431-9150-3a41affffb9a 32
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-4045-00 00006404500 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4045-00) / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01) 2006-06-08 0000-00-00 No No Current 0006-4045-01 00006404501 0.5 mL in 1 VIAL, SINGLE-DOSE 0.5 ml Historical 0006-4045-41 00006404541 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4045-41) / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01) 2006-06-08 0000-00-00 No No Current