NDC 13533-503 - FESILTY

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
13533-503
Package NDCs from labels
13533-503-02
Manufacturer
Grifols USA LLC | Biotest AG | Grifols Therapeutics LLC | Laboratorios Grifols, S.A. | Instituto Grifols, S.A. | Prothya Biosolutions Belgium | TechPharm GmbH | GBA Pharma GmbH
Effective date
2026-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FESILTYGrifols USA LLC | Biotest AG | Grifols Therapeutics LLC | Laboratorios Grifols, S.A. | Instituto Grifols, S.A. | Prothya Biosolutions Belgium | TechPharm GmbH | GBA Pharma GmbH2026-08-20PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-503-02FESILTY50 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1 mL20 mg in 1mL2

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 54 of 54 · 1,064 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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