FDA.reportPublic FDA data

GARDASIL 9

Product NDC
50090-2443
11-digit product format
500902443
Labeler code
50090
Product ID
50090-2443_ea946e06-0c6d-4735-8718-bf71ca7648d1
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
Marketing end
0000-00-00
Substance
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 strength
30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharmacologic 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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 productproduct50090-2443IInactivated by FDA2026-07-31
excluded packagepackage50090-244350090-2443-0IInactivated by FDA2026-07-31

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2443-02020-01-31C16284748780-19d75b9d0-c142-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GARDASIL 9 safely and effectively. See full prescribing information for GARDASIL 9. GARDASIL ® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2443-0GARDASIL 910 mL in 1 CARTONINJECTION, SUSPENSION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2443-0ML - Milliliter50090-2443db2a08ed-f57a-401f-9986-40765935f7e712019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2443GARDASIL 9 (HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE, RECOMBINANT) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]14Legacy NDC, 1 package rows20180308_8355d971-d377-4d1d-973e-a65798bce7f9.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
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 formatDescriptionUnitsStatus
50090-2443-05009024430010 mL in 1 CARTON10 mlHistorical