FDA.reportPublic FDA data

NDC 42874-014-01 - Flublok

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
42874-014
Requested NDC
42874-014-01
Package NDCs from labels
42874-014-01, 42874-014-10
Manufacturer
Protein Sciences Corporation | Hospira, Inc. | WuXi AppTec, Inc.
Effective date
2014-11-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Flublok - Protein Sciences Corporation | Hospira, Inc. | WuXi AppTec, Inc.Protein Sciences Corporation | Hospira, Inc. | WuXi AppTec, Inc.2014-11-21VACCINE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42874-014-102020-08-04C16284748780-19d75b9d0-ea70-f424-e053-dadaa90a57ceThese 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 2014-2015 Formula Initial U.S. Approval: 2013
42874-014-102020-01-31C16284748780-19d75b9d0-ea70-f424-e053-dadaa90a57ceThese 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 2014-2015 Formula Initial U.S. Approval: 2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42874-014-01ML - Milliliter42874-014434ad0c0-81a3-4400-ac94-da51995d34d312014-09-03
42874-014-10ML - Milliliter42874-0140a347005-6983-436f-abfa-9678b4e2420412014-08-01

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 46 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: 593YOG76RN
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: 593YOG76RN
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC51da05ce-e3c4-4ef5-a845-dc869152e17f2022-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr Talbots Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLC6a1322c7-7767-4569-aa22-9d2e363312832022-08-30WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMedsSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5b580-1d9f-3081-e053-2995a90a80312022-08-08WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse BreatheSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5c313-046f-b0a7-e053-2a95a90a2a072022-08-08WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation123bd10a-90c7-499e-97f6-acf7e0f0fb4e2022-07-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCfad9615f-7004-415d-9f69-ee9ff95f00672022-07-12WarningsExact identifier
unii: 451W47IQ8X
BHI ConstipationDIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEEDMediNatura Inc0365b75b-fee4-4c1d-89ab-c692bdd73f752022-07-07WarningsExact identifier
unii: 451W47IQ8X
Natrium Muriaticum 6XSODIUM CHLORIDESeroyal USA0ebf18de-12fe-0bc4-e054-00144ff88e882022-07-07WarningsExact identifier
unii: 451W47IQ8X
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.