Ezetimibe and Simvastatin

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 · 1 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 · 1 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 4 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 5 · 172 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

Related Records#

• All packages for product NDC 60219-1157
• DailyMed label: Ezetimibe and Simvastatin
• FDA application 208831
• Company: Amneal Pharmaceuticals NY LLC
• Search ingredient/name matches

Related UNII Ingredients#

Packages#

Related DailyMed Labels#