Home NDC 50268-763 Temozolomide
Product NDC 50268-763
11-digit product format 502680763
Labeler code 50268
Product ID 50268-763_6890fc4a-df68-1d2b-e053-2a91aa0ae134
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 140 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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50268-763-12 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50268-763-12 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50268-763-12 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50268-763-12 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50268-763-12 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50268-763-12 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50268-763-12 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50268-763-12 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50268-763-12 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50268-763-12 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50268-763-12 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50268-763-12 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203691-001 TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 A203691-002 TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 A203691-003 TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 A203691-004 TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 A203691-005 TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 A203691-006 TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-763 TEMOZOLOMIDE CAPSULE [AVPAK] 6 Legacy NDC 20240110_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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-763-12 50268076312 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-763-12) > 1 CAPSULE in 1 BLISTER PACK (50268-763-11) 20 blister pack 2017-03-23 0000-00-00 No No Current