FDA.reportPublic FDA data

NDC11 00597044053

This exact 11-digit normalized identifier can correspond to more than one FDA hyphenation. FDA.report preserves the exact identifier and exposes every structurally valid candidate without guessing.

Possible FDA NDC forms#

Package NDC, Product root table
Package NDCProduct root
00597-0440-5300597-0440
00597-440-5300597-440
0597-0440-530597-0440

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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PradaxaDABIGATRAN ETEXILATEBoehringer Ingelheim Pharmaceuticals, Inc.9ac0a64a-8666-45f7-9d4f-40fd894f7e6d2025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0597-0440-53
ndc (product): 0597-0440
ndc11 (package): 00597044053

Reported adverse events (FAERS/openFDA)#

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