FDA.reportPublic FDA data

GARDASIL

Product NDC
50090-1523
Requested package NDC
50090-1523-1
11-digit product format
500901523
Labeler code
50090
Product ID
50090-1523_0150b986-99af-492a-a1de-0b1b2a33a4f5
Type
VACCINE
Nonproprietary name
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
BLA125126
Marketing category
BLA
Marketing start
2006-06-08
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
Active strength
20 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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-152350090-1523-1IInactivated 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
50090-1523-12023-01-30C16284748780-1f386c649-d84a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GARDASIL safely and effectively. See full prescribing information for GARDASIL. GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] Suspension for intramuscular injection Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1523-1GARDASIL10 in 1 CARTONINJECTION, SUSPENSION109
50090-1523-9GARDASIL.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION.59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1523GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]9Legacy NDC, 2 package rows20200121_ab802261-3eeb-4eea-af6a-31c830ac91f8.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125126GardasilHuman Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1523-15009015230110 VIAL, SINGLE-DOSE in 1 CARTON (50090-1523-1) > .5 mL in 1 VIAL, SINGLE-DOSE (50090-1523-9) 2006-06-080000-00-00NoNoCurrent