FDA.reportPublic FDA data

GARDASIL 9

Product NDC
50090-4958
11-digit product format
500904958
Labeler code
50090
Product ID
50090-4958_9c20bdb4-d253-4287-b794-c1e898b7cdef
Type
VACCINE
Nonproprietary name
Human Papillomavirus 9-valent Vaccine, Recombinant
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4958DDiscontinued by firm2026-07-31
excluded packagepackage50090-495850090-4958-1DDiscontinued by firm2026-07-31

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
50090-4958-0GARDASIL 9.5 mL in 1 SYRINGE, GLASSINJECTION, SUSPENSION.514
50090-4958-1GARDASIL 91 in 1 VIALINJECTION, SUSPENSION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4958-0ML - Milliliter50090-49589dc29a58-313a-4670-b687-03a7a1fc1cdb12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4958GARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]14Current NDC, 2 package rows20250516_d099cf95-a7cc-4636-994d-226c3f866cdc.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125508Gardasil 9Human Papillomavirus 9-valent Vaccine, Recombinant351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597103Gardasil 9 0.5 ML Prefilled SyringePSNd099cf95-a7cc-4636-994d-226c3f866cdc14
1597101human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 mL Prefilled SyringePSNd099cf95-a7cc-4636-994d-226c3f866cdc14
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]SBDd099cf95-a7cc-4636-994d-226c3f866cdc14
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 SyringeSCDd099cf95-a7cc-4636-994d-226c3f866cdc14
1597103Gardasil 9, human Papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 ML Prefilled SyringeSYd099cf95-a7cc-4636-994d-226c3f866cdc14
1597101human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 ML Prefilled SyringeSYd099cf95-a7cc-4636-994d-226c3f866cdc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-4958-050090495800.5 mL in 1 SYRINGE, GLASSHistorical
50090-4958-1500904958011 SYRINGE, GLASS in 1 VIAL (50090-4958-1) / .5 mL in 1 SYRINGE, GLASS (50090-4958-0) 2014-12-10NoNoHistorical