FDA.reportPublic FDA data

NDC 55513-155 - BLINCYTO

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
55513-155
Package NDCs from labels
55513-155-01
Manufacturer
Amgen, Inc
Effective date
2026-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BLINCYTO - Amgen, IncAmgen, Inc2026-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-155BLINCYTO (BLINATUMOMAB) KIT [AMGEN, INC]40Unmatched20250511_38b482a8-960b-4591-9857-5031ecb830aa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BLINATUMOMABACTIVE INGREDIENT4FR53SIF3ABLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
BLINATUMOMABACTIVE MOIETY4FR53SIF3ABLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
LYSINE HYDROCHLORIDEINACTIVE INGREDIENTJNJ23Q2COMBLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
TREHALOSE DIHYDRATEINACTIVE INGREDIENT7YIN7J07X4BLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7

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 12 of 12 · 221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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