FDA.reportPublic FDA data

NDC 71104-045 - ALPROLIX

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
71104-045
Package NDCs from labels
71104-045-01
Manufacturer
Bioverativ Therapeutics Inc. | Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Eurofins Biopharma Product Testing Munich GmbH | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Packaging Coordinators, LLC | Lonza Biologics, Inc. | PPD Development Ireland Ltd. | Avista Pharma Solutions, Inc. | Eurofins Biopharma Product Testing Ireland Limited | Rechon Life Science AB | Biogen U.S. Corporation | Sharp Packaging Services, LLC | Biogen MA Inc.
Effective date
2024-05-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALPROLIXBioverativ Therapeutics Inc. | Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Eurofins Biopharma Product Testing Munich GmbH | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Packaging Coordinators, LLC | Lonza Biologics, Inc. | PPD Development Ireland Ltd. | Avista Pharma Solutions, Inc. | Eurofins Biopharma Product Testing Ireland Limited | Rechon Life Science AB | Biogen U.S. Corporation | Sharp Packaging Services, LLC | Biogen MA Inc.2024-05-16PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71104-045ALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOVERATIV THERAPEUTICS INC.]12Unmatched20240517_2fb3fb92-379d-4683-80d6-b06c0a7dc063.zip

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 21 of 46 · 912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb2b780d3-26ac-4e7c-a0f2-78991bee32a82025-05-07Exact identifier
unii: 451W47IQ8X
VirimmuneACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2024-2025), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUMDeseret Biologicals, Inc.ac036ad8-6f48-4c15-b021-dc9bbb7e642e2025-05-06WarningsExact identifier
unii: 451W47IQ8X
Gout Relief 3310-SCELERY SEED MEDICAGO SATIVA WHOLEBispit Canada Ltd.346f68ea-73aa-99c6-e063-6394a90af5d52025-05-05WarningsExact identifier
unii: 451W47IQ8X
Seasonal Allergy ReliefONION, SODIUM CHLORIDE, HISTAMINE DIHYDROCHLORIDE, CUCUMBER, GALPHIMIA GLAUCA FLOWERING TOP, AND STRYCHNOS NUX-VOMICA SEEDHyland's Inc.101e6b80-cdae-49e5-acfb-f056448856ec2025-04-30WarningsExact identifier
unii: 451W47IQ8X
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDEBETTER LIVING BRANDS LLC33ee7b77-0871-4df8-e063-6394a90ac4792025-04-29WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC6d43fa91-0940-437f-ba70-b2d3f977593e2025-04-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Nat Mur 6XSODIUM CHLORIDEHyland's Inc.dcf0e2ac-3b69-3ae4-e053-2a95a90aaf412025-04-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM68 PelletsPHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARBBestmade Natural Products32423a04-31d1-7477-e063-6394a90aecac2025-04-08WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat Mur 8xNATRUM MURIATICUMBestmade Natural Products31e0e16d-e4df-cd9a-e063-6394a90abcc12025-04-03WarningsExact identifier
unii: 451W47IQ8X
Kidneyforce-HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREABioActive Nutritional, Inc.0c0f0c0c-10c2-47eb-aad6-bbffb6e167992025-04-02WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13 Lactose FreeCALC PHOS KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products303590c5-8a66-aafc-e063-6294a90a1a4e2025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13CALC PHOS, KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products2fffab7f-0d4b-0e96-e063-6294a90a34d82025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNAT MURBestmade Natural Productse9e9a4f6-5104-3c6f-e053-2995a90a11652025-03-21WarningsExact identifier
unii: 451W47IQ8X
Pituitary LiquescenceCAULOPHYLLUM THALICTROIDES, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CIMICIFUGA RACEMOSA, NATRUM MURIATICUM, CINCHONA OFFICINALIS, ADRENOCORTICOTROPHINNutritional Specialties, Inc.292ca967-abe8-4ae1-b2fe-942531a1e14a2025-03-20WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20 Lactose FreeCALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products30394e7e-170f-7b9d-e063-6394a90afcdb2025-03-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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