FDA.reportPublic FDA data

NDC11 00078081301

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
00078-0813-0100078-0813
00078-0813-100078-0813
00078-813-0100078-813
0078-0813-010078-0813

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
TOBREXTOBRAMYCINNovartis Pharmaceuticals Corporation5b66bba3-cf97-4a9c-b618-ba5f277f20f62025-12-16Warnings, Adverse reactionsExact identifier
ndc (package): 0078-0813-01
ndc (product): 0078-0813
ndc11 (package): 00078081301

Reported adverse events (FAERS/openFDA)#

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