Isotretinoin

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.

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.

Observed Orange Book normalized TE history#

Additional Listing Data#

Finished product

Yes

Brand name base

Isotretinoin

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 · 6 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 · 2 matching rows.

Related Records#

• DailyMed label: Isotretinoin
• FDA application 216633
• Company: Zydus Pharmaceuticals USA Inc.
• Search ingredient/name matches

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#