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 49 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Chloride for IrrigationSODIUM CHLORIDE FOR IRRIGATIONB. Braun Medical Inc.5bd9b176-0402-4a3f-a6b4-c3f393fc092a2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEFresenius Kabi USA, LLCe6169d3b-39d2-47f9-8d5b-b53ec069a7222021-07-23Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
0.9% SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstc755e41b-acba-7234-e053-2995a90aff0f2021-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: 451W47IQ8X
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC4a655cde-283f-4ec8-a3d9-5f539c55c2042021-05-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCed8fd0c1-ac42-4267-877e-ceadf3831c902021-04-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dr. Talbots Vital 12CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUCTalbot's Pharmaceuticals Family Products, LLCc10bb804-8169-63da-e053-2a95a90a83062021-04-28WarningsExact identifier
unii: 451W47IQ8X
Dr. Talbots Infant Daily Allergy ReliefALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLCc0963200-67dd-6349-e053-2a95a90adde12021-04-22WarningsExact identifier
unii: 451W47IQ8X
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMedical Purchasing Solutions, LLCc3f8e83c-4fb9-91da-e053-2a95a90abd632021-04-12Adverse reactionsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline Mist Live BetterSODIUM CHLORIDECVS Pharmacyccc3ab8c-b22f-420d-869b-f2a65b8c71802021-03-13WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationaeaed9cb-b629-4019-88d2-a916179427de2021-02-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GUNA KIDNEY PLUSCALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -Guna spab8dacd94-8da1-4a8d-e053-2995a90acb672021-02-04WarningsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRUM MURIATICUMTrue Botanica, LLCb30b2880-28a1-47bd-83e7-da885a7c6f772021-01-24WarningsExact identifier
unii: 451W47IQ8X
Met-ToxARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODESwHITE mANUFACTURING INC DBA MICRO-WESTe65db4c2-0bc7-4c50-8f18-b36ee004c4f52021-01-21WarningsExact identifier
unii: 451W47IQ8X
HPZECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCCWhite Manufacturing Inc. DBA Micro-Westdfbb5a35-8dfe-48f4-9177-6cb52fb440902021-01-21WarningsExact identifier
unii: 451W47IQ8X
MetalALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIANET Remediesf7682a4e-c767-4429-98aa-e8c5ef6560a62021-01-19WarningsExact identifier
unii: 451W47IQ8X
3% Sodium Chloride3% SODIUM CHLORIDEBecton Dickinson and Companya8058593-48af-457a-b0f0-166935c7d10c2021-01-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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