Temozolomide

Product NDC
0093-7600
11-digit product format
000937600
Labeler code
0093
Product ID
0093-7600_81643f17-65fb-4936-8b57-45aede72857a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA078879
Marketing category
ANDA
Marketing start
2013-08-12
Marketing end
0000-00-00
Substance
TEMOZOLOMIDE
Active strength
20 mg/1
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-7600DDiscontinued by firm2026-08-17
excluded packagepackage0093-76000093-7600-41DDiscontinued by firm2026-08-17
excluded packagepackage0093-76000093-7600-57DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7600-41d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7600-57d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7600-41f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7600-57f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7600-412ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7600-572ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7600-41a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7600-57a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7600-41cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7600-57cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7600-41cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7600-57cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7600-41302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7600-57302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7600-41ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7600-57ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7600-410efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7600-570efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7600-41ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7600-57ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7600-41367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7600-57367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7600-41557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7600-57557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078879-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORAL2010-03-01
A078879-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORAL2010-03-01
A078879-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORAL2010-03-01
A078879-004TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORAL2010-03-01
A078879-005TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORAL2010-03-01
A078879-006TEMOZOLOMIDETEMOZOLOMIDE180MGCAPSULE / ORAL2010-03-01

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078879-001TEMOZOLOMIDE5MGCAPSULE / ORAL2010-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A078879-002TEMOZOLOMIDE20MGCAPSULE / ORAL2010-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A078879-003TEMOZOLOMIDE100MGCAPSULE / ORAL2010-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A078879-004TEMOZOLOMIDE250MGCAPSULE / ORAL2010-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A078879-005TEMOZOLOMIDE140MGCAPSULE / ORAL2010-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A078879-006TEMOZOLOMIDE180MGCAPSULE / ORAL2010-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078879-001TEMOZOLOMIDE5MGCAPSULE / ORAL2010-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078879-002TEMOZOLOMIDE20MGCAPSULE / ORAL2010-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078879-003TEMOZOLOMIDE100MGCAPSULE / ORAL2010-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078879-004TEMOZOLOMIDE250MGCAPSULE / ORAL2010-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078879-005TEMOZOLOMIDE140MGCAPSULE / ORAL2010-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078879-006TEMOZOLOMIDE180MGCAPSULE / ORAL2010-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078879-001TEMOZOLOMIDE5MGCAPSULE / ORAL2010-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078879-002TEMOZOLOMIDE20MGCAPSULE / ORAL2010-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078879-003TEMOZOLOMIDE100MGCAPSULE / ORAL2010-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078879-004TEMOZOLOMIDE250MGCAPSULE / ORAL2010-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078879-005TEMOZOLOMIDE140MGCAPSULE / ORAL2010-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078879-006TEMOZOLOMIDE180MGCAPSULE / ORAL2010-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078879-001TEMOZOLOMIDE5MGCAPSULE / ORAL2010-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078879-002TEMOZOLOMIDE20MGCAPSULE / ORAL2010-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078879-003TEMOZOLOMIDE100MGCAPSULE / ORAL2010-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078879-004TEMOZOLOMIDE250MGCAPSULE / ORAL2010-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078879-005TEMOZOLOMIDE140MGCAPSULE / ORAL2010-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078879-006TEMOZOLOMIDE180MGCAPSULE / ORAL2010-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078879-001TEMOZOLOMIDE5MGCAPSULE / ORAL2010-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078879-002TEMOZOLOMIDE20MGCAPSULE / ORAL2010-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078879-003TEMOZOLOMIDE100MGCAPSULE / ORAL2010-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078879-004TEMOZOLOMIDE250MGCAPSULE / ORAL2010-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078879-005TEMOZOLOMIDE140MGCAPSULE / ORAL2010-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078879-006TEMOZOLOMIDE180MGCAPSULE / ORAL2010-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078879-001TEMOZOLOMIDE5MGCAPSULE / ORAL2010-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078879-002TEMOZOLOMIDE20MGCAPSULE / ORAL2010-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078879-003TEMOZOLOMIDE100MGCAPSULE / ORAL2010-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078879-004TEMOZOLOMIDE250MGCAPSULE / ORAL2010-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078879-005TEMOZOLOMIDE140MGCAPSULE / ORAL2010-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078879-006TEMOZOLOMIDE180MGCAPSULE / ORAL2010-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078879-001TEMOZOLOMIDE5MGCAPSULE / ORAL2010-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078879-002TEMOZOLOMIDE20MGCAPSULE / ORAL2010-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078879-003TEMOZOLOMIDE100MGCAPSULE / ORAL2010-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078879-004TEMOZOLOMIDE250MGCAPSULE / ORAL2010-03-0103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078879-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078879-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078879-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078879-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078879-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078879-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078879-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078879-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078879-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078879-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078879-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078879-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078879-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078879-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078879-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078879-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078879-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078879-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078879-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078879-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078879-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078879-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078879-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078879-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078879-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078879-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078879-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078879-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078879-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078879-006AB1bb7c543d1eb4…
2020-11-12 02:37 UTC2020-11A078879-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078879-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078879-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078879-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078879-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078879-006AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078879-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078879-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078879-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078879-004AB13f01610625f2…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7600-41EA - Each0093-7600d6a2bdcc-60a1-43ba-b2c2-5547d5ad93b912013-09-04
0093-7600-57EA - Each0093-76009c1508e1-4f63-4510-b9f0-a702f41602da12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMOZOLOMIDEACTIVE INGREDIENTYF1K15M17YTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
TEMOZOLOMIDEACTIVE MOIETYYF1K15M17YTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
GELATININACTIVE INGREDIENT2G86QN327LTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ETEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
SHELLACINACTIVE INGREDIENT46N107B71OTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMOZOLOMIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]5