Home DailyMed 6dad88d9-e73f-4d12-8e28-7abca243d049 TEMOZOLOMIDE CAPSULES Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited
Effective date 2022-10-17
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 5
Source legacy-cache
Hydrated at 2026-08-01 21:50:53 Label at a glance# Product temozolomide
Active ingredient TEMOZOLOMIDE
Label structure 1 sections
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 23 matching rows.
temozolomide ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 3 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER D&C YELLOW NO. 10 FERRIC OXIDE RED Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 3 · 118 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206750-001 TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2017-07-31 A206750-002 TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2017-07-31 A206750-003 TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2017-07-31 A206750-004 TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2017-07-31 A206750-005 TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2017-07-31 A206750-006 TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2017-07-31
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 · 264 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A206750-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206750-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206750-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206750-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206750-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206750-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2017-07-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206750-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206750-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206750-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206750-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206750-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206750-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2017-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206750-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206750-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206750-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206750-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206750-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206750-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2017-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206750-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206750-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206750-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206750-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206750-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206750-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2017-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206750-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206750-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206750-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206750-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206750-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206750-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2017-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206750-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206750-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206750-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206750-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206750-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206750-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2017-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206750-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206750-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206750-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206750-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2017-07-31 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 264 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.