Temozolomide
- Product NDC
- 62175-240
- 11-digit product format
- 621750240
- Labeler code
- 62175
- Product ID
- 62175-240_4c996fcd-3d95-467b-85c3-220acd507d39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA203898
- Marketing category
- ANDA
- Marketing start
- 2016-02-10
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 62175-240 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 62175-240 | 62175-240-19 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 62175-240 | 62175-240-24 | D | Discontinued by firm | 2026-08-07 |
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 | 62175-240-19 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 62175-240-24 | 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 | 62175-240-19 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 62175-240-24 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203898-001 | TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2016-02-10 | ||
| A203898-002 | TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2016-02-10 | ||
| A203898-003 | TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | AB | 2016-02-10 | |
| A203898-004 | TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | AB | 2016-02-10 | |
| A203898-005 | TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | AB | 2016-02-10 | |
| A203898-006 | TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | AB | 2016-02-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203898-003 | AB |
| A203898-004 | AB |
| A203898-005 | AB |
| A203898-006 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203898-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2016-02-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203898-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2016-02-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203898-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | AB | 2016-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203898-004 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | AB | 2016-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203898-005 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | AB | 2016-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203898-006 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | AB | 2016-02-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2016-02-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2016-02-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | AB | 2016-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-004 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | AB | 2016-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-005 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | AB | 2016-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-006 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | AB | 2016-02-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203898-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2016-02-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203898-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2016-02-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203898-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | AB | 2016-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203898-004 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | AB | 2016-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203898-005 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | AB | 2016-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203898-006 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | AB | 2016-02-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203898-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2016-02-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203898-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2016-02-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203898-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2016-02-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203898-004 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2016-02-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203898-005 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2016-02-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203898-006 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2016-02-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203898-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2016-02-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203898-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2016-02-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203898-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2016-02-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203898-004 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2016-02-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203898-005 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2016-02-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203898-006 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2016-02-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203898-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2016-02-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203898-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2016-02-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203898-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2016-02-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203898-004 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2016-02-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203898-005 | TEMOZOLOMIDE | 180MG | CAPSULE / ORAL | 2016-02-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203898-006 | TEMOZOLOMIDE | 250MG | CAPSULE / ORAL | 2016-02-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203898-001 | TEMOZOLOMIDE | 5MG | CAPSULE / ORAL | 2016-02-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203898-002 | TEMOZOLOMIDE | 20MG | CAPSULE / ORAL | 2016-02-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203898-003 | TEMOZOLOMIDE | 100MG | CAPSULE / ORAL | 2016-02-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203898-004 | TEMOZOLOMIDE | 140MG | CAPSULE / ORAL | 2016-02-10 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203898-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203898-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203898-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203898-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203898-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203898-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203898-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203898-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203898-006 | AB | 1 | 6a471c1ec25d… |
| 2019-09-15 20:21 UTC | 2019-09 | A203898-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A203898-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A203898-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A203898-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A203898-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A203898-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203898-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A203898-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A203898-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A203898-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A203898-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A203898-006 | AB | 1 | ea99ee380514… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203898-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203898-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203898-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203898-006 | AB | 1 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Temozolomide | TEMOZOLOMIDE | OPKO Pharmaceuticals, LLC | 9dff10ec-6a55-47b6-a458-b7c39e32dc55 | 2026-07-27 | Warnings, Adverse reactions | 203898 ANDA203898 |
| Temozolomide | TEMOZOLOMIDE | OPKO Pharmaceuticals, LLC | f6d762ea-fff0-43e8-b67d-bef19e883dd8 | 2026-07-27 | Warnings, Adverse reactions | 203898 ANDA203898 |
| Temozolomide | TEMOZOLOMIDE | OPKO Pharmaceuticals, LLC | f743f7e0-74cf-47e5-bf21-f2b75d2596dc | 2026-07-27 | Warnings, Adverse reactions | 203898 ANDA203898 |
| Temozolomide | TEMOZOLOMIDE | OPKO Pharmaceuticals, LLC | b3f69c67-db30-4266-8075-9b18c71c9fc1 | 2026-07-27 | Warnings, Adverse reactions | 203898 ANDA203898 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62175-240-19 | 62175024019 | 5 CAPSULE in 1 BOTTLE (62175-240-19) | 5 capsule | 2016-02-10 | 0000-00-00 | No | No | Current |
| 62175-240-24 | 62175024024 | 14 CAPSULE in 1 BOTTLE (62175-240-24) | 14 capsule | 2016-02-10 | 0000-00-00 | No | No | Current |