FDA.reportPublic FDA data

NDC 58394-135 - 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
58394-135
Package NDCs from labels
58394-135-03
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
58394-135-03BeneFIX5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,5 mL1000 [iU] in 5mL45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58394-135BENEFIX (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 5 of 90 · 1,790 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVOCATE Sterile Alcohol Prep PadsISOPROPYL ALCOHOLPHARMA SUPPLY, INCa87dd40d-a9b1-4bb5-acc2-2d00abc2034a2026-07-30WarningsExact identifier
rxcui: 797544
unii: ND2M416302
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
70% Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions57ac6fef-21de-e214-e063-6394a90a6c9e2026-07-28WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC57acc1ff-2564-1e61-e063-6394a90a3c912026-07-28WarningsExact identifier
unii: ND2M416302
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Pharma care IPA WipesISOPROPYL ALCOHOLEnviro Specialty Chemicals Inc26ce919a-1765-4b44-9114-24ea7383a9872026-07-24WarningsExact identifier
rxcui: 797544
unii: ND2M416302
DOCTOR INKS IPA WIPESISOPROPYL ALCOHOLEnviro Specialty Chemicals Incf65f0ec4-fa2c-487d-a8cc-41cbb8c140a42026-07-24WarningsExact identifier
rxcui: 797544
unii: ND2M416302
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
rxcui: 797544
unii: ND2M416302
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
rxcui: 797544
unii: ND2M416302
PROVEN MEDICAL TESTING Alcohol Prep PadsISOPROPYL ALCOHOLProven Medical Testing, LLC21e0f7ea-e73e-4461-ab2b-50d456e1d70d2026-07-22WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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