Temozolomide

Product NDC
50268-761
11-digit product format
502680761
Labeler code
50268
Product ID
50268-761_ed872311-129b-1fc7-e053-2a95a90a19e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA203691
Marketing category
ANDA
Marketing start
2017-03-23
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50268-761DDiscontinued by firm2026-08-17
excluded packagepackage50268-76150268-761-12DDiscontinued 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 · 4 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 packagepackage50268-761-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50268-761-12f5e01cc5f278…a2eaf40c39c3…

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
A203691-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORALAB2015-05-08
A203691-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORALAB2015-05-08
A203691-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORALAB2015-05-08
A203691-004TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORALAB2015-05-08
A203691-005TEMOZOLOMIDETEMOZOLOMIDE180MGCAPSULE / ORALAB2015-05-08
A203691-006TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORALABRS2015-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203691-001AB
A203691-002AB
A203691-003AB
A203691-004AB
A203691-005AB
A203691-006AB

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203691-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2015-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2015-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2015-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2015-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2015-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-006TEMOZOLOMIDE250MGCAPSULE / ORALABRS2015-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203691-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2015-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2015-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2015-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2015-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2015-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-006TEMOZOLOMIDE250MGCAPSULE / ORALABRS2015-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2015-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2015-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2015-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2015-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2015-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-006TEMOZOLOMIDE250MGCAPSULE / ORALABRS2015-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203691-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2015-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2015-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2015-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2015-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2015-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-006TEMOZOLOMIDE250MGCAPSULE / ORALABRS2015-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2015-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2015-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2015-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2015-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2015-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-006TEMOZOLOMIDE250MGCAPSULE / ORALABRS2015-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2015-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2015-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2015-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2015-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2015-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-006TEMOZOLOMIDE250MGCAPSULE / ORALABRS2015-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203691-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2015-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203691-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2015-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203691-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2015-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203691-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2015-05-0803ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203691-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203691-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203691-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203691-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203691-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203691-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203691-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203691-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203691-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203691-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203691-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203691-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203691-004AB103ed91905a0d…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-761-11EA - Each50268-761c699762c-5d98-43ae-8e07-b9bdaed3882d12017-05-03
50268-761-12EA - Each50268-761aedb9661-02a5-4e4d-ae88-40060b1d709912017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-761TEMOZOLOMIDE CAPSULE [AVPAK]6Legacy NDC20240110_36563b1d-61f2-43e5-b7c1-c6d9036ef28b.zip

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
TemozolomideTEMOZOLOMIDEAmneal Pharmaceuticals LLC6c8529ec-8936-4fec-a1a5-2b285c7e48592024-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203691
application number: ANDA203691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-761-125026807611220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-761-12) > 1 CAPSULE in 1 BLISTER PACK (50268-761-11) 20 blister pack2017-03-230000-00-00NoNoCurrent