Home NDC 0781-2694 Temozolomide
Product NDC 0781-2694
11-digit product format 007812694
Labeler code 0781
Product ID 0781-2694_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 140 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 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.
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 N021029-001 TEMODAR TEMOZOLOMIDE 5MG CAPSULE / ORAL RLD 1999-08-11 N021029-002 TEMODAR TEMOZOLOMIDE 20MG CAPSULE / ORAL RLD 1999-08-11 N021029-003 TEMODAR TEMOZOLOMIDE 100MG CAPSULE / ORAL RLD 1999-08-11 N021029-004 TEMODAR TEMOZOLOMIDE 250MG CAPSULE / ORAL RLD 1999-08-11 N021029-005 TEMODAR TEMOZOLOMIDE 140MG CAPSULE / ORAL RLD 2006-10-19 N021029-006 TEMODAR TEMOZOLOMIDE 180MG CAPSULE / ORAL RLD 2006-10-19
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 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 N021029-001 TEMODAR 5MG CAPSULE / ORAL RLD 1999-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021029-002 TEMODAR 20MG CAPSULE / ORAL RLD 1999-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021029-003 TEMODAR 100MG CAPSULE / ORAL RLD 1999-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021029-004 TEMODAR 250MG CAPSULE / ORAL RLD 1999-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021029-005 TEMODAR 140MG CAPSULE / ORAL RLD 2006-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021029-006 TEMODAR 180MG CAPSULE / ORAL RLD 2006-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021029-001 TEMODAR 5MG CAPSULE / ORAL RLD 1999-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021029-002 TEMODAR 20MG CAPSULE / ORAL RLD 1999-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021029-003 TEMODAR 100MG CAPSULE / ORAL RLD 1999-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021029-004 TEMODAR 250MG CAPSULE / ORAL RLD 1999-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021029-005 TEMODAR 140MG CAPSULE / ORAL RLD 2006-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021029-006 TEMODAR 180MG CAPSULE / ORAL RLD 2006-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021029-001 TEMODAR 5MG CAPSULE / ORAL RLD 1999-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021029-002 TEMODAR 20MG CAPSULE / ORAL RLD 1999-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021029-003 TEMODAR 100MG CAPSULE / ORAL RLD 1999-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021029-004 TEMODAR 250MG CAPSULE / ORAL RLD 1999-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021029-005 TEMODAR 140MG CAPSULE / ORAL RLD 2006-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021029-006 TEMODAR 180MG CAPSULE / ORAL RLD 2006-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021029-001 TEMODAR 5MG CAPSULE / ORAL RLD 1999-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021029-002 TEMODAR 20MG CAPSULE / ORAL RLD 1999-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021029-003 TEMODAR 100MG CAPSULE / ORAL RLD 1999-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021029-004 TEMODAR 250MG CAPSULE / ORAL RLD 1999-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021029-005 TEMODAR 140MG CAPSULE / ORAL RLD 2006-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021029-006 TEMODAR 180MG CAPSULE / ORAL RLD 2006-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021029-001 TEMODAR 5MG CAPSULE / ORAL RLD 1999-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021029-002 TEMODAR 20MG CAPSULE / ORAL RLD 1999-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021029-003 TEMODAR 100MG CAPSULE / ORAL RLD 1999-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021029-004 TEMODAR 250MG CAPSULE / ORAL RLD 1999-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021029-005 TEMODAR 140MG CAPSULE / ORAL RLD 2006-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021029-006 TEMODAR 180MG CAPSULE / ORAL RLD 2006-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021029-001 TEMODAR 5MG CAPSULE / ORAL RLD 1999-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021029-002 TEMODAR 20MG CAPSULE / ORAL RLD 1999-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021029-003 TEMODAR 100MG CAPSULE / ORAL RLD 1999-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021029-004 TEMODAR 250MG CAPSULE / ORAL RLD 1999-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021029-005 TEMODAR 140MG CAPSULE / ORAL RLD 2006-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021029-006 TEMODAR 180MG CAPSULE / ORAL RLD 2006-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021029-001 TEMODAR 5MG CAPSULE / ORAL RLD 1999-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021029-002 TEMODAR 20MG CAPSULE / ORAL RLD 1999-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021029-003 TEMODAR 100MG CAPSULE / ORAL RLD 1999-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021029-004 TEMODAR 250MG CAPSULE / ORAL RLD 1999-08-11 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0781-2694-44 2020-02-02 These highlights do not include all the information needed to use Temozolomide Capsules safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. Temozolomide capsules, for oral use Temozolomide for injection marketed as TEMODAR ® , for intravenous use Initial U.S. Approval: 1999 0781-2694-75 2020-02-02 These highlights do not include all the information needed to use Temozolomide Capsules safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. Temozolomide capsules, for oral use Temozolomide for injection marketed as TEMODAR ® , for intravenous use Initial U.S. Approval: 1999 0781-2694-44 2020-01-31 These highlights do not include all the information needed to use Temozolomide Capsules safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. Temozolomide capsules, for oral use Temozolomide for injection marketed as TEMODAR ® , for intravenous use Initial U.S. Approval: 1999 0781-2694-75 2020-01-31 These highlights do not include all the information needed to use Temozolomide Capsules safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES. Temozolomide capsules, for oral use Temozolomide for injection marketed as TEMODAR ® , for intravenous use Initial U.S. Approval: 1999
DailyMed Socrata Ingredients# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TEMODAR TEMOZOLOMIDE Merck Sharp & Dohme LLC 046a9011-3911-4d3f-a15f-fbb56d5aad56 2026-02-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 021029 application number: NDA021029
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-2694-44 00781269444 1 BOTTLE, GLASS in 1 CARTON (0781-2694-44) > 14 CAPSULE in 1 BOTTLE, GLASS 2013-08-12 0000-00-00 No No Current 0781-2694-75 00781269475 1 BOTTLE, GLASS in 1 CARTON (0781-2694-75) > 5 CAPSULE in 1 BOTTLE, GLASS 2013-08-12 0000-00-00 No No Current