NDC 80534-6350-01

This exact product or package identity exists in FDA auxiliary data but is not present in the current primary NDC product table. The package identity is preserved; status rows are reported source observations, not medical conclusions.

Requested NDC
80534-6350-01
Product root
80534-6350
Identity scope
Package
Primary current NDC product row
Not present

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage80534-635080534-6350-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XENOVIEWXENON XE 129 HYPERPOLARIZEDPolarean, Inc.70e33fe3-c722-439b-b3db-c2a22f229c8a2025-05-30Warnings, Adverse reactionsExact identifier
ndc (product): 80534-6350
ndc11 (package): 80534635001

Reported adverse events (FAERS/openFDA)#

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