NDC11 53097057160

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 NDC	Product root
53097-0571-60	53097-0571
53097-571-60	53097-571

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 date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53097-571	53097-571-60	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MARINOL	DRONABINOL	ThePharmaNetwork, LLC	d0efeeec-640d-43c3-8f0a-d31324a11c68	2023-02-14	Warnings, Adverse reactions	Exact identifier ndc (package): 53097-571-60 ndc (product): 53097-571 ndc11 (package): 53097057160

Reported adverse events (FAERS/openFDA)#

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