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 36 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC239a5af1-7498-480f-862c-ab7c3d89d1832024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyebc8b008-a8b3-4c41-89e4-b413f7aab89f2024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: 451W47IQ8X
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: 451W47IQ8X
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.4510fe59-cc28-4585-925f-42508a60abd02024-05-13WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.47a0313f-36df-4fa6-a828-c9e1946ba9b02024-05-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCf0cc6713-4d47-49be-8116-901c99002b6b2024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.7f22c06b-6b4d-4b49-a4b2-d2169f2bd6532024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff2024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLC97001218-086c-430a-9e0d-6c7031c91d942024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCfe5b5182-c859-4c74-b2e0-467be5b2e3292024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.f2475fa3-ab1d-4b81-8127-b58cd0790a542024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Weed Grass AntigensALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,Energique, Inc.8a28f56a-6010-42e3-b360-e6e22b86222a2024-05-02WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCc2467d57-cd2d-4409-bcc0-50128bd01bba2024-04-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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