FDA.reportPublic FDA data

Flublok

Product NDC
42874-013
11-digit product format
428740013
Labeler code
42874
Product ID
42874-013_fb2aad7e-82d2-47c0-9eb3-08ac62641a47
Type
VACCINE
Nonproprietary name
Influenza Vaccine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Protein Sciences Corporation
Application
BLA125285
Marketing category
BLA
Marketing start
2013-11-01
Marketing end
0000-00-00
Substance
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGEN
Active strength
45 ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct42874-013DDiscontinued by firm2026-07-31
excluded packagepackage42874-01342874-013-10DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42874-013-102020-08-04C16284748780-19855e2a2-378c-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Flublok ® safely and effectively. See full prescribing information for Flublok. Flublok (Influenza Vaccine) Sterile Solution for Intramuscular Injection 2013-2014 Formula Initial U.S. Approval: 2013
42874-013-102019-11-27C16284748780-19855e2a2-378c-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Flublok ® safely and effectively. See full prescribing information for Flublok. Flublok (Influenza Vaccine) Sterile Solution for Intramuscular Injection 2013-2014 Formula Initial U.S. Approval: 2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42874-013-01ML - Milliliter42874-013bbcb93c9-1a7b-423f-a302-0d05e2237d2112013-11-04
42874-013-10ML - Milliliter42874-013d8bf7bf3-6684-4a4f-ac9a-15b609e0622512013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGENACTIVE INGREDIENT1SE9Z7D2QRFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGENACTIVE INGREDIENT1IQZ1WCE3YFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGENACTIVE INGREDIENTAYR0WZX7JHFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGENACTIVE MOIETY1SE9Z7D2QRFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGENACTIVE MOIETY1IQZ1WCE3YFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGENACTIVE MOIETYAYR0WZX7JHFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QSFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEINACTIVE INGREDIENTE1W4N241FOFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]1

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125285FlublokInfluenza Vaccine351(a)Rx2026-06-01