Opana

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

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 · 48 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 8 · 308 observed states.

Observed Orange Book patent history#

Patent history page 1 of 53 · 2,114 observed states.

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

• DailyMed label: Opana ER
• FDA application 201655
• Company: Endo Pharmaceuticals Inc.
• Search ingredient/name matches

Related UNII Ingredients#

Related DailyMed Labels#