Temozolomide

Product NDC
0781-2692
11-digit product format
007812692
Labeler code
0781
Product ID
0781-2692_11eaca7f-fe49-4e46-9af8-949cca418fbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc.
Application
NDA021029
Marketing category
NDA AUTHORIZED GENERIC
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
2023-12-31
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 productproduct0781-2692DDiscontinued by firm2026-08-17
excluded packagepackage0781-26920781-2692-44DDiscontinued by firm2026-08-17
excluded packagepackage0781-26920781-2692-75DDiscontinued 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 packagepackage0781-2692-75d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-2692-44d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2692-75f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2692-44f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2692-752ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2692-442ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2692-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2692-44a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2692-75cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2692-44cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2692-75cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2692-44cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2692-75302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2692-44302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2692-75ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2692-44ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2692-750efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2692-440efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-2692-75ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-2692-44ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-2692-75367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-2692-44367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-2692-75557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-2692-44557ba5c1ecfa…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
N021029-001TEMODARTEMOZOLOMIDE5MGCAPSULE / ORALRLD1999-08-11
N021029-002TEMODARTEMOZOLOMIDE20MGCAPSULE / ORALRLD1999-08-11
N021029-003TEMODARTEMOZOLOMIDE100MGCAPSULE / ORALRLD1999-08-11
N021029-004TEMODARTEMOZOLOMIDE250MGCAPSULE / ORALRLD1999-08-11
N021029-005TEMODARTEMOZOLOMIDE140MGCAPSULE / ORALRLD2006-10-19
N021029-006TEMODARTEMOZOLOMIDE180MGCAPSULE / ORALRLD2006-10-19

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 06:07:402026-07N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-1103ed91905a0d…

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 ZIP2022-06N021029-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021029-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021029-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021029-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021029-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021029-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021029-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021029-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021029-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021029-004AB187673890dc5c…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2692-44EA - Each0781-2692028f7a13-bb32-4c05-8896-6c4d5af67e2812013-09-04
0781-2692-75EA - Each0781-2692b58f6c55-b419-4f76-b5e6-e17d79ac5a4712013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TemozolomideACTIVE INGREDIENTYF1K15M17YTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
TemozolomideACTIVE MOIETYYF1K15M17YTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
alcoholINACTIVE INGREDIENT3K9958V90MTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
ferric oxide redINACTIVE INGREDIENT1K09F3G675TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
gelatinINACTIVE INGREDIENT2G86QN327LTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ETEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
shellacINACTIVE INGREDIENT46N107B71OTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
stearic acidINACTIVE INGREDIENT4ELV7Z65APTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
tartaric acidINACTIVE INGREDIENTW4888I119HTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4
waterINACTIVE INGREDIENT059QF0KO0RTEMOZOLOMIDE CAPSULE [SANDOZ INC.]4

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
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 021029
application number: NDA021029

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-2692-44007812692441 BOTTLE, GLASS in 1 CARTON (0781-2692-44) > 14 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent
0781-2692-75007812692751 BOTTLE, GLASS in 1 CARTON (0781-2692-75) > 5 CAPSULE in 1 BOTTLE, GLASS2013-08-120000-00-00NoNoCurrent