Temozolomide

Product NDC
62559-921
Requested package NDC
62559-921-14
11-digit product format
625590921
Labeler code
62559
Product ID
62559-921_ea20ab6a-6558-4114-8983-c8df85adff0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA203490
Marketing category
ANDA
Marketing start
2020-11-16
Marketing end
2023-02-28
Substance
TEMOZOLOMIDE
Active strength
20 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62559-92162559-921-14DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203490-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORAL2016-07-13
A203490-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORAL2016-07-13
A203490-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORAL2016-07-13
A203490-004TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORAL2016-07-13
A203490-005TEMOZOLOMIDETEMOZOLOMIDE180MGCAPSULE / ORAL2016-07-13
A203490-006TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORAL2016-07-13

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203490-001TEMOZOLOMIDE5MGCAPSULE / ORAL2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A203490-002TEMOZOLOMIDE20MGCAPSULE / ORAL2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A203490-003TEMOZOLOMIDE100MGCAPSULE / ORAL2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A203490-004TEMOZOLOMIDE140MGCAPSULE / ORAL2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A203490-005TEMOZOLOMIDE180MGCAPSULE / ORAL2016-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A203490-006TEMOZOLOMIDE250MGCAPSULE / ORAL2016-07-1384e616aacf4f…
2026-08-18 06:07:402026-07A203490-001TEMOZOLOMIDE5MGCAPSULE / ORAL2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A203490-002TEMOZOLOMIDE20MGCAPSULE / ORAL2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A203490-003TEMOZOLOMIDE100MGCAPSULE / ORAL2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A203490-004TEMOZOLOMIDE140MGCAPSULE / ORAL2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A203490-005TEMOZOLOMIDE180MGCAPSULE / ORAL2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A203490-006TEMOZOLOMIDE250MGCAPSULE / ORAL2016-07-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203490-001TEMOZOLOMIDE5MGCAPSULE / ORAL2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203490-002TEMOZOLOMIDE20MGCAPSULE / ORAL2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203490-003TEMOZOLOMIDE100MGCAPSULE / ORAL2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203490-004TEMOZOLOMIDE140MGCAPSULE / ORAL2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203490-005TEMOZOLOMIDE180MGCAPSULE / ORAL2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203490-006TEMOZOLOMIDE250MGCAPSULE / ORAL2016-07-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203490-001TEMOZOLOMIDE5MGCAPSULE / ORAL2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203490-002TEMOZOLOMIDE20MGCAPSULE / ORAL2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203490-003TEMOZOLOMIDE100MGCAPSULE / ORAL2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203490-004TEMOZOLOMIDE140MGCAPSULE / ORAL2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203490-005TEMOZOLOMIDE180MGCAPSULE / ORAL2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203490-006TEMOZOLOMIDE250MGCAPSULE / ORAL2016-07-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203490-001TEMOZOLOMIDE5MGCAPSULE / ORAL2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203490-002TEMOZOLOMIDE20MGCAPSULE / ORAL2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203490-003TEMOZOLOMIDE100MGCAPSULE / ORAL2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203490-004TEMOZOLOMIDE140MGCAPSULE / ORAL2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203490-005TEMOZOLOMIDE180MGCAPSULE / ORAL2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203490-006TEMOZOLOMIDE250MGCAPSULE / ORAL2016-07-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203490-001TEMOZOLOMIDE5MGCAPSULE / ORAL2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203490-002TEMOZOLOMIDE20MGCAPSULE / ORAL2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203490-003TEMOZOLOMIDE100MGCAPSULE / ORAL2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203490-004TEMOZOLOMIDE140MGCAPSULE / ORAL2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203490-005TEMOZOLOMIDE180MGCAPSULE / ORAL2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203490-006TEMOZOLOMIDE250MGCAPSULE / ORAL2016-07-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203490-001TEMOZOLOMIDE5MGCAPSULE / ORAL2016-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203490-002TEMOZOLOMIDE20MGCAPSULE / ORAL2016-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203490-003TEMOZOLOMIDE100MGCAPSULE / ORAL2016-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203490-004TEMOZOLOMIDE140MGCAPSULE / ORAL2016-07-13b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203490-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203490-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203490-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203490-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203490-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203490-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203490-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203490-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203490-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203490-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203490-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203490-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203490-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203490-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203490-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203490-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203490-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203490-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203490-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203490-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203490-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203490-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203490-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203490-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203490-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203490-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203490-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203490-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203490-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203490-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203490-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203490-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203490-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203490-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203490-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203490-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203490-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203490-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203490-005AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203490-006AB187673890dc5c…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-921-14625590921141 BOTTLE, GLASS in 1 CARTON (62559-921-14) > 14 CAPSULE in 1 BOTTLE, GLASS2020-11-162023-02-28NoNoCurrent