Temozolomide

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.

Product history page 1 of 7 · 246 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Additional Listing Data#

Finished product

Yes

Brand name base

Temozolomide

Listing expiration

2026-12-31

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#

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 · 1 matching rows.

Related Records#

• All packages for product NDC 16729-048
• DailyMed label: Temozolomide
• FDA application 201528
• Company: Accord Healthcare Inc.
• Search ingredient/name matches

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#