FDA.reportPublic FDA data

NDC 58394-134 - BeneFIX

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
58394-134
Package NDCs from labels
58394-134-03
Manufacturer
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SA
Effective date
2025-02-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BeneFIX - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SAWyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SA2025-02-24PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58394-134-03BeneFIX5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,5 mL500 [iU] in 5mL45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58394-134BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]45Unmatched20250227_85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAGULATION FACTOR IX RECOMBINANT HUMANACTIVE INGREDIENT382L14738LBENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25
COAGULATION FACTOR IX RECOMBINANT HUMANACTIVE MOIETY382L14738LBENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25
GLYCINEINACTIVE INGREDIENTTE7660XO1CBENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25
HISTIDINEINACTIVE INGREDIENT4QD397987EBENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25
SUCROSEINACTIVE INGREDIENTC151H8M554BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25
WATERINACTIVE INGREDIENT059QF0KO0RBENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]25

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 32 of 90 · 1,790 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Pharma-C Company 70 Isopropyl Alcohol PadsISOPROPYL ALCOHOLKleen Test Products Corporationc5df867b-1b8d-4e38-8c32-7d528b9825902025-12-09WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Rhinomel ManukaSODIUM CHLORIDEMelcare Biomedical Pty Ltd35a7ce7d-4a26-e3f0-e063-6294a90ad66f2025-12-09WarningsExact identifier
unii: 451W47IQ8X
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDESOLA Pharmaceuticals, LLC4d0bfd28-460a-48ba-bd17-cf75e56d62f42025-12-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Vamousse Lice TreatmentPEDICULICIDEAlliance Pharma Inc.75db3fab-5523-4880-e053-2a91aa0a925e2025-12-05WarningsExact identifier
unii: 451W47IQ8X
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 451W47IQ8X
THE FLOWER REMEDY Happy HeartGENTIANELLA AMARELLA, ULEX EUROPAEUS, ILEX AQUIFOLIUM, LONICERA CAPRIFOLIUM, SINAPIS ARVENSIS, ORNITHOGALUM UMBELLATUM, CASTANEA SATIVA, SALIX VITELLINA, IGNATIA AMARA, NATRUM MURIATICUMThe Flower Remedy6decd8fe-7593-4421-926c-f924002400322025-12-03WarningsExact identifier
unii: 451W47IQ8X
ALCOHOL PREP PAD70% ISOPROPY ALCOHOL SWABPurCel Labs LLC450c39fd-d172-492e-e063-6294a90aa3962025-12-03WarningsExact identifier
rxcui: 797544
unii: ND2M416302
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fbb53e-b547-0615-e053-2995a90a51512025-12-03WarningsExact identifier
unii: ND2M416302
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fb4069-b926-266b-e053-2995a90acab92025-12-03WarningsExact identifier
unii: ND2M416302
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat MurNATRIUM MURIATICUMBM Private Limited37b12318-dff9-e32a-e063-6394a90a18e82025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARBM Private Limited37c27f80-7689-c5a1-e063-6294a90a619b2025-12-02WarningsExact identifier
unii: 451W47IQ8X
CHLORAPREPCHLORAPREPHF Acquisition Co LLC, DBA HealthFirst44fe08e0-4e9c-8bd6-e063-6394a90a0e2b2025-12-02WarningsExact identifier
unii: ND2M416302
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist MeijerSODIUM CHLORIDEMeijer, Inc.445c8f4f-0519-0764-e063-6294a90a8b392025-12-01WarningsExact identifier
unii: 451W47IQ8X
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
unii: 451W47IQ8X
Sterile alcohol padSTERILE ALCOHOL PADKingstar Medical (Xianning) Co., Ltd.39df5fc7-f66e-1605-e063-6394a90a00542025-11-24WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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