TEMOZOLOMIDE CAPSULES

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#

Producttemozolomide
Active ingredientTEMOZOLOMIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1092-6 in bottle of 5 capsules

Temozolomide Capsules, 5 mg

Rx  only

5 capsules

Temozolomide capsules, 5 mg
Temozolomide capsules, 5 mg

NDC 70771-1093-6 in bottle of 5 capsules

Temozolomide Capsules, 20 mg

Rx  only

5 capsules

Temozolomide capsules, 20 mg
Temozolomide capsules, 20 mg

NDC 70771-1094-6 in bottle of 5 capsules

Temozolomide Capsules, 100 mg

Rx  only

5 capsules

Temozolomide capsules, 100 mg
Temozolomide capsules, 100 mg

NDC 70771-1095-6 in bottle of 5 capsules

Temozolomide Capsules, 140 mg

Rx  only

5 capsules

Temozolomide capsules, 140 mg
Temozolomide capsules, 140 mg

NDC 70771-1096-6 in bottle of 5 capsules

Temozolomide Capsules, 180 mg

Rx  only

5 capsules

Temozolomide capsules, 180 mg
Temozolomide capsules, 180 mg

NDC 70771-1097-6 in bottle of 5 capsules

Temozolomide Capsules, 250 mg

Rx  only

5 capsules

Temozolomide capsules, 250 mg
Temozolomide capsules, 250 mg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 118 matching rows.

Source Document#

Source XML

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206750-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31
A206750-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31
A206750-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31
A206750-004TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31
A206750-005TEMOZOLOMIDETEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-31
A206750-006TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A206750-001AB
A206750-002AB
A206750-003AB
A206750-004AB
A206750-005AB
A206750-006AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-09-14 22:38:342026-08A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-08-18 06:07:402026-07A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A206750-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206750-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206750-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206750-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206750-005AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206750-006AB1c2088c7a36db…
2026-09-14 22:38:342026-08A206750-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206750-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206750-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A206750-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A206750-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A206750-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A206750-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206750-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206750-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-004AB1fd3edfee7708…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a86159d9-ba4a-4641-bdb4-096a312e8ef26dad88d9-e73f-4d12-8e28-7abca243d0492024-12-04Exact identifier
spl set id: 6dad88d9-e73f-4d12-8e28-7abca243d049

Reported adverse events (FAERS/openFDA)#

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