Temozolomide

Product NDC: 51862-087
11-digit product format: 518620087
Labeler code: 51862
Product ID: 51862-087_46492e4f-c3ac-4af2-9fab-9484620a7208
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temozolomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA206413
Marketing category: ANDA
Marketing start: 2016-10-10
Marketing end: 2019-09-30
Substance: TEMOZOLOMIDE
Active strength: 180 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51862-087		D	Discontinued by firm	2026-10-16
excluded package	package	51862-087	51862-087-14	D	Discontinued by firm	2026-10-16
excluded package	package	51862-087	51862-087-51	D	Discontinued by firm	2026-10-16

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.

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	51862-087-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-087-14	`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	51862-087-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-087-14	`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	51862-087-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-087-14	`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	51862-087-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-087-14	`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	51862-087-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-087-14	`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	51862-087-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-087-14	`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	51862-087-51	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-087-14	`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	51862-087-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-087-14	`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	51862-087-51	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-087-14	`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	51862-087-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-087-14	`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	51862-087-51	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-087-14	`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	51862-087-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51862-087-14	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206413-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-12
A206413-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-12
A206413-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-12
A206413-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-12
A206413-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-12
A206413-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206413-001	AB
A206413-002	AB
A206413-003	AB
A206413-004	AB
A206413-005	AB
A206413-006	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A206413-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206413-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206413-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206413-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206413-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206413-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206413-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206413-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206413-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-12	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A206413-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206413-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206413-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206413-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206413-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206413-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206413-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206413-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206413-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206413-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206413-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206413-004	AB	1	`fd3edfee7708…`

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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-087-14	EA - Each	51862-087	dcfea067-e290-4674-854d-437852b51c36	1	2016-12-07
51862-087-51	EA - Each	51862-087	913df4bb-1b3f-44ef-8861-0015a2ae22bd	1	2016-12-07

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YF1K15M17Y	TEMOZOLOMIDE	85622-93-1	TEMOZOLOMIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temozolomide	Mayne Pharma Inc. \| IDT Australia Limited	2019-08-19	HUMAN PRESCRIPTION DRUG LABEL	3