FDA.reportPublic FDA data

NDC11 00078056115

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
00078-0561-1500078-0561
00078-561-1500078-561
0078-0561-150078-0561

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
Exforge HCTAMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporation18d7820d-471f-4ee2-9ec6-25d8d27c77de2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0078-0561-15
ndc (product): 0078-0561
ndc11 (package): 00078056115

Reported adverse events (FAERS/openFDA)#

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