Dexmethylphenidate Hydrochloride

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 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 9 · 344 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 344 observed states.

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 observed states.

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product

Yes

Brand name base

Dexmethylphenidate Hydrochloride

Brand name suffix

Extended-Release

Listing expiration

2027-12-31

Active Ingredients#

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: Dexmethylphenidate Hydrochloride Extended-Release
• FDA application 021802
• Company: Sandoz Inc
• Search ingredient/name matches

Related UNII Ingredients#

Packages#

Related DailyMed Labels#