Rexulti

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 · 20 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Orange Book patents#

Current patent rows page 1 of 1 · 76 matching rows.

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 30 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 7 · 246 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Observed Orange Book patent history#

Patent history page 1 of 63 · 2,519 observed states.

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 16 · 612 observed states.

Additional Listing Data#

Finished product

Yes

Brand name base

Rexulti

Listing expiration

2027-12-31

Active Ingredients#

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

DailyMed Product Concepts#

DailyMed Package Descriptions#

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 · 3 matching rows.

Related Records#

• DailyMed label: Rexulti
• FDA application 205422
• Company: REMEDYREPACK INC.
• Search ingredient/name matches

Related UNII Ingredients#

Packages#

Related DailyMed Labels#