Ondansetron
- Product NDC
- 70518-4685
- 11-digit product format
- 705184685
- Labeler code
- 70518
- Product ID
- 70518-4685_560986a0-e4eb-5c4c-e063-6394a90aa552
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078152
- Marketing category
- ANDA
- Marketing start
- 2026-06-29
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078152-001 | ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | |
| A078152-002 | ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078152-001 | AB |
| A078152-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078152-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078152-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2007-06-27 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A078152-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078152-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078152-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078152-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078152-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078152-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078152-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078152-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078152-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078152-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078152-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078152-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078152-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078152-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078152-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078152-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078152-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078152-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078152-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078152-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078152-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078152-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A078152-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A078152-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A078152-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A078152-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078152-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078152-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078152-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078152-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078152-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078152-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078152-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078152-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A078152-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078152-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078152-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078152-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078152-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078152-002 | AB | 1 | 3a93d1ddd44b… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ondansetron
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ONDANSETRON | 8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4AF302ESOS | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312087 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9c3ad9c1-474e-4331-a017-09cec46702d8 | Available on FDA.report |
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 | St. Mary's Medical Park Pharmacy | f175a336-433b-7ab2-e053-2995a90ad5ca | 2026-08-26 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | c0d827d0-333f-4187-ac75-9dc7d34b6169 | 2026-08-11 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals Inc. | 7975d78c-9bb6-467a-9c2d-ea15bde7af5c | 2026-08-07 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | A-S Medication Solutions | 5a81a39b-051b-414e-a6b0-d844de4e9ab4 | 2026-07-29 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | A-S Medication Solutions | 02ddd5f5-76d3-4f1c-9af3-d39e05a19c29 | 2026-07-29 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | St. Mary's Medical Park Pharmacy | 41366a20-0727-0446-e063-6294a90a957f | 2026-07-28 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 9c3ad9c1-474e-4331-a017-09cec46702d8 | 2026-07-07 | Warnings, Adverse reactions | 078152 ANDA078152 70518-4685 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc | 4575d288-be0c-f6c3-e063-6294a90af708 | 2026-06-29 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | 3c34ca82-9705-4784-be7c-8b50351d14fc | 2026-06-12 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals Inc. | e87a5803-e872-43f7-8a15-79aa236e8c07 | 2026-06-11 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | BluePoint Laboratories | ed1132ec-c2cd-4646-b69d-26663bb937a4 | 2026-06-10 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 5bacb621-1261-25d9-e053-2991aa0afa3b | 2026-04-08 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | df736abd-9cec-4e90-e053-2995a90aab5e | 2026-03-13 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals, Inc. | 50383ef5-6e6e-63a7-e054-00144ff88e88 | 2026-03-04 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | ef6ce203-4ae3-19c9-e053-2995a90af796 | 2026-02-27 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | d117de5f-64e5-464c-b782-de0f07e66c8e | 2026-01-20 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | Glenmark Pharmaceuticals Inc., USA | eee5217a-eba8-463a-812d-bf3c66f0934f | 2026-01-08 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | f29f5cfa-3cc4-7d53-e053-2995a90ae844 | 2025-12-26 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | AvKARE | 352de988-d166-c2d8-e063-6294a90acc01 | 2025-11-17 | Warnings, Adverse reactions | 078152 ANDA078152 |
| Ondansetron | ONDANSETRON | Proficient Rx LP | 81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74 | 2025-11-01 | Warnings, Adverse reactions | 078152 ANDA078152 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 70518-4685-0 | 70518468500 | 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (70518-4685-0) | 2026-06-29 | No | No | Current |