Temozolomide
- Product NDC
- 23155-778
- 11-digit product format
- 231550778
- Labeler code
- 23155
- Product ID
- 23155-778_e1982c81-2588-45cf-94f7-160a700709e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA078879
- Marketing category
- ANDA
- Marketing start
- 2022-06-15
- Marketing end
- 0000-00-00
- Substance
- TEMOZOLOMIDE
- Active strength
- 180 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 23155-778 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 23155-778 | 23155-778-71 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 23155-778 | 23155-778-72 | D | Discontinued by firm | 2026-10-15 |
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.
| 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 | 23155-778-72 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 23155-778-71 | 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 | 23155-778-72 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 23155-778-71 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078879-001 | TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-002 | TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-003 | TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-004 | TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-005 | TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | ||
| A078879-006 | TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-005 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078879-006 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2010-03-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078879-004 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2010-03-01 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-14 00:12 UTC | 2019-12 | A078879-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078879-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078879-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078879-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078879-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078879-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078879-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078879-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078879-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078879-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078879-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078879-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078879-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078879-006 | AB | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078879-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078879-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078879-003 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078879-004 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078879-005 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078879-006 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078879-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078879-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078879-003 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078879-004 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078879-005 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078879-006 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A078879-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078879-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078879-003 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078879-004 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078879-005 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078879-006 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078879-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078879-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078879-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078879-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078879-005 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078879-006 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078879-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078879-002 | AB | 1 | 3a93d1ddd44b… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 23155-778-71 | 23155077871 | 5 CAPSULE in 1 BOTTLE (23155-778-71) | 5 capsule | 2022-06-15 | 0000-00-00 | No | No | Current |
| 23155-778-72 | 23155077872 | 14 CAPSULE in 1 BOTTLE (23155-778-72) | 14 capsule | 2022-06-15 | 0000-00-00 | No | No | Current |