temozolomide

Product NDC
68382-751
11-digit product format
683820751
Labeler code
68382
Product ID
68382-751_2da71848-9a09-45b2-820e-c43f37b0fe3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206750
Marketing category
ANDA
Marketing start
2017-10-26
Marketing end
0000-00-00
Substance
TEMOZOLOMIDE
Active strength
5 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 productproduct68382-751DDiscontinued by firm2026-10-15
excluded packagepackage68382-75168382-751-67DDiscontinued by firm2026-10-15
excluded packagepackage68382-75168382-751-96DDiscontinued by firm2026-10-15

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 · 6 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 packagepackage68382-751-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-751-67d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-751-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-751-67f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A206750-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31
A206750-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31
A206750-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31
A206750-004TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31
A206750-005TEMOZOLOMIDETEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-31
A206750-006TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206750-001AB
A206750-002AB
A206750-003AB
A206750-004AB
A206750-005AB
A206750-006AB

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 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-10-15 13:18:302026-09A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-31c2088c7a36db…
2026-09-14 22:38:342026-08A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-3184e616aacf4f…
2026-08-18 06:07:402026-07A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206750-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2017-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2017-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2017-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2017-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206750-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2017-07-31fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206750-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206750-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206750-005AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206750-006AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206750-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206750-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206750-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206750-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206750-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206750-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206750-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206750-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206750-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206750-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206750-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206750-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206750-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206750-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206750-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206750-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206750-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206750-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206750-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206750-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206750-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206750-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206750-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206750-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206750-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206750-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206750-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206750-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206750-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206750-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206750-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206750-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206750-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206750-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206750-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206750-006AB14b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-751-67EA - Each68382-751ec68f6f5-e67e-48d6-9cfe-0450805e9add12018-06-11
68382-751-96EA - Each68382-75193a2d510-3837-4656-9777-c5e4fdc9dde012018-06-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-751-676838207516714 CAPSULE in 1 BOTTLE (68382-751-67) 14 capsule2017-10-260000-00-00NoNoCurrent
68382-751-96683820751965 CAPSULE in 1 BOTTLE (68382-751-96) 5 capsule2017-10-260000-00-00NoNoCurrent