Emtricitabine and Tenofovir Disoproxil Fumarate

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.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Therapeutic equivalence codes#

Current TE-code 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 · 150 observed states.

Observed Orange Book exclusivity history#

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

DailyMed Dashboard NDC Coverage#

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 · 2 matching rows.

Related Records#

• All packages for product NDC 42291-439
• DailyMed label: Emtricitabine and Tenofovir Disoproxil Fumarate
• FDA application 209721
• Company: AvKARE
• Search ingredient/name matches

Related UNII Ingredients#

Packages#

Related DailyMed Labels#