Application 078539
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No |
| 002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 8MG BASE | No | No |
| 003 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 24MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078539-001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | |
| A078539-002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | |
| A078539-003 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078539-001 | AB |
| A078539-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078539-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078539-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078539-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078539-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078539-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078539-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078539-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078539-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078539-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078539-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078539-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078539-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078539-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078539-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078539-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078539-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078539-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078539-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078539-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078539-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078539-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078539-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078539-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078539-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078539-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078539-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078539-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078539-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078539-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078539-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078539-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078539-002 | AB | 1 | 74a2ff9319b5… |
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 Hydrochloride | ONDANSETRON HYDROCHLORIDE | Asclemed USA, Inc. | 65b0b2e2-37fd-4d08-9674-954d62bb531a | 2025-01-27 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | b43e15d6-b778-7575-e053-2995a90a93a0 | 2025-01-14 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | AvPAK | e4766235-ac44-ca93-78a6-66d4ded33ada | 2025-01-09 | Warnings, Adverse reactions | 078539 ANDA078539 50268-622 50268-621 |
| Ondansetron HCL | ONDANSETRON HCL | Advanced Rx of Tennessee, LLC | af75407e-82aa-136f-e053-2995a90a429b | 2024-12-31 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron HCL | ONDANSETRON HCL | Advanced Rx of Tennessee, LLC | af830edc-ce9e-b038-e053-2a95a90ae974 | 2024-12-31 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Quality Care Products, LLC | 2e0b1b09-9e68-4728-82d5-1f86510a0f2a | 2024-12-19 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Quality Care Products LLC | 54e8981e-6880-4d4f-bc46-600c2af59698 | 2024-12-18 | Warnings, Adverse reactions | 078539 ANDA078539 55700-627 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Quality Care Products LLC | 89091629-d15e-4e95-aed8-8bc983c78302 | 2024-12-18 | Warnings, Adverse reactions | 078539 ANDA078539 55700-631 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals, Inc. | 2553816f-161e-ac86-e063-6394a90aad6d | 2024-10-25 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 8585e68b-965f-4f95-a5df-eea023cd5f82 | 2024-08-21 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 3aeb533a-e72c-4af8-9867-b71d2eba9a49 | 2024-08-20 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 115e8fb5-61f5-4719-8eb3-063b7ca194ae | 2024-08-08 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | d6694136-7591-4f23-8415-f2aa3c8bab40 | 2024-07-16 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 91bfbc0e-86a3-8ac6-e053-2a95a90af432 | 2024-06-19 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NUCARE PHARMACEUTICALS INC | 8d696b8c-eba6-505e-e053-2995a90acb5d | 2024-06-18 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7f315229-7e8f-67fd-e053-2a91aa0a8cb6 | 2024-06-12 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NuCare Pharmceuticals,Inc. | 67395789-0ac7-2244-e053-2a91aa0a652a | 2024-06-07 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | A-S Medication Solutions | 674ea285-8f84-4603-9655-82200c523fe5 | 2023-10-25 | Warnings, Adverse reactions | 078539 ANDA078539 50090-3178 50090-3185 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | 65f01335-452e-42c6-a59b-4eb03badc55a | 2023-06-01 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | A-S Medication Solutions | f8f371c7-09f8-426c-ae22-753cd5626da3 | 2023-01-23 | Warnings, Adverse reactions | 078539 ANDA078539 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0179-0247 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-0248 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 10544-575 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 16714-159 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-159 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-160 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 16714-160 | Ondansetron | Ondansetron | NorthStar Rx LLC | ANDA | Current |
| 33261-417 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-745 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42708-044 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-044 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-044 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-059 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-059 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-059 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | QPharma Inc | ANDA | Current |
| 43063-792 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-792 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-792 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-792 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-792 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-509 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | medsource pharmaceuticals | ANDA | Current |
| 50090-3178 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3178 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3178 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3178 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3185 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3185 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3185 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3185 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4671 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4671 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4671 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-621 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | AvPAK | ANDA | Current |
| 50268-621 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | AvPAK | ANDA | Current |
| 50268-621 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | AvPAK | ANDA | Current |
| 50268-621 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | AvPAK | ANDA | Current |
| 50268-622 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | AvPAK | ANDA | Current |
| 50268-622 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | AvPAK | ANDA | Current |
| 50268-622 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | AvPAK | ANDA | Current |
| 50268-622 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | AvPAK | ANDA | Current |
| 50436-0187 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-0187 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-1880 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-1880 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Unit Dose Services | ANDA | Current |
| 51655-415 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53002-0571 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0601 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-1121 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | DOH CENTRAL PHARMACY | ANDA | Current |
| 54348-819 | Ondansetron | ONDANSETRON | PharmPak, Inc. | ANDA | Current |
| 54348-819 | Ondansetron | ONDANSETRON | PharmPak, Inc. | ANDA | Current |
| 54348-821 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Pharmpak, Inc. | ANDA | Current |
| 54348-821 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Pharmpak, Inc. | ANDA | Current |
| 55154-8176 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8176 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-8176 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-627 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-627 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-627 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-627 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-631 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-631 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-631 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-631 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-075 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-075 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-075 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-075 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-075 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-076 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-076 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-076 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-076 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-076 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Rising Health, LLC | ANDA | Current |
| 58118-7500 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-7500 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-7500 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-636 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-636 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-636 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-636 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |