Ondansetron
- Product NDC
- 63187-483
- 11-digit product format
- 631870483
- Labeler code
- 63187
- Product ID
- 63187-483_19d4f41e-82d5-4eb2-94f7-de85f787725d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078050
- Marketing category
- ANDA
- Marketing start
- 2007-08-13
- 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
- No
- Listing certified through
- 2020-12-31
- 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 | 63187-483 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 63187-483 | 63187-483-10 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63187-483 | 63187-483-15 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 63187-483 | 63187-483-20 | D | Discontinued by firm | 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 | 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 | 63187-483-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-483-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-483-15 | 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 | 63187-483-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-483-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-483-15 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078050-001 | ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | |
| A078050-002 | ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078050-001 | AB |
| A078050-002 | 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 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078050-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078050-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-08-13 | 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 | A078050-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078050-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078050-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078050-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078050-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078050-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078050-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078050-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078050-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078050-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078050-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078050-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078050-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078050-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078050-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078050-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078050-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078050-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078050-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078050-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078050-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078050-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078050-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078050-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078050-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078050-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078050-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078050-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078050-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078050-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078050-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078050-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078050-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078050-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078050-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078050-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078050-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078050-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078050-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078050-002 | AB | 1 | bb7c543d1eb4… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-483-10 | EA - Each | 63187-483 | 56232a98-e5c4-4dd8-bd09-4699b4435162 | 1 | 2023-08-08 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-483-10 | 63187048310 | 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-483-10) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-483-15 | 63187048315 | 15 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-483-15) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-483-20 | 63187048320 | 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-483-20) | 2018-11-01 | 0000-00-00 | No | No | Current |