Ondansetron
- Product NDC
- 33358-512
- 11-digit product format
- 333580512
- Labeler code
- 33358
- Product ID
- 33358-512_355a69d9-5b4d-4d6c-be1c-213b9e0ad096
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- RxChange Co.
- Application
- ANDA090469
- Marketing category
- ANDA
- Marketing start
- 2014-12-02
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 33358-512 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 33358-512 | 33358-512-30 | I | Inactivated by FDA | 2026-08-17 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 33358-512-30 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 33358-512-30 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090469-001 | ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | |
| A090469-002 | ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090469-001 | AB |
| A090469-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090469-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090469-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090469-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090469-002 | AB | 1 | bb7c543d1eb4… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9bd4853-037c-6968-f4d4-9bb9a0efd1ea | Product name | 2 | 20250722 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 32e23bc9-ce14-4555-bb6d-bcb654d7d296 | Product name | 1 | 20201015 |
| e459f50a-1553-4aab-b6bd-1e5f0c211c49 | Product name | 1 | 20201015 |
| 909480fe-0d18-c1c1-a658-0bd9a7131822 | Product name | 5 | 20170829 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33358-512-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bec9-f424-e053-dadaa90a57ce | Ondansetron Orally Disintegrating Tablets, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33358-512-30 | Ondansetron | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33358-512-30 | EA - Each | 33358-512 | ccf97ab2-b23d-4f70-81bb-3dd8cebfd852 | 1 | 2015-03-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ONDANSETRON | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [RXCHANGE CO.] | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | 66ac9c17-bea7-4f8d-8a27-a1e0f9e65945 | 2026-08-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | 70b48280-ef74-472b-abc3-128962bfcb05 | 2026-08-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 3c4cda2f-13d9-42c5-b449-77deb06c8de5 | 2026-08-03 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | HAWAII REPACK, INC. | b76c5cc9-f1ca-428b-8989-36a66802b650 | 2026-07-17 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 18063a64-a4c0-4bad-911b-00df5c7bb65d | 2026-07-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | 77397df5-5a4f-41b2-98bc-f817a1e497fc | 2026-07-02 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 822404ad-af08-4c62-ae38-7d9819e86079 | 2026-07-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | St. Mary's Medical Park Pharmacy | 3207cf04-73b7-24ce-e054-00144ff8d46c | 2026-06-30 | Warnings, Adverse reactions | 090469 ANDA090469 |
| ONDANSETRON | ONDANSETRON | Direct Rx | b38feff2-900a-4e0c-8260-8f090edbc0bc | 2026-03-17 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | A-S Medication Solutions | 378d0963-d026-4478-8202-fbb636904a37 | 2026-02-18 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 9dff6676-e69e-779d-e053-2995a90a7c81 | 2026-01-27 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 76666e7e-3312-6f9d-e053-2991aa0af705 | 2026-01-23 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | f2b502e2-03ed-fe5c-e053-2995a90a368e | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | db9a0d22-9339-4319-e053-2a95a90a9592 | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | e07c38c0-e1c2-01de-e053-2995a90a390a | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 9558d296-8edd-4aa1-875a-6247f9a8374d | 2025-09-15 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 10afd68b-877f-4819-a314-39f2d56d5db9 | 2025-09-15 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da | 2025-09-04 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | b50c1767-8a50-49ab-be31-6533021ae7c4 | 2025-08-21 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Rising Pharma Holdings, Inc. | eb74425c-c635-4d99-8e98-e63e7359fb89 | 2025-07-17 | Warnings, Adverse reactions | 090469 ANDA090469 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 0e62c438-359f-4cec-a785-9c7ac09fa6f8 | 2 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 0e62c438-359f-4cec-a785-9c7ac09fa6f8 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33358-512-30 | 33358051230 | 30 in 1 BOTTLE | Historical |