Application 077851
- Type
- ANDA
- Sponsor
- NATCO PHARMA LTD
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077851-001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | |
| A077851-002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077851-001 | AB |
| A077851-002 | 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 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 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 | A077851-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077851-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077851-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077851-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077851-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077851-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077851-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077851-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077851-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077851-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077851-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077851-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077851-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077851-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077851-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077851-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077851-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077851-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077851-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077851-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077851-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077851-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077851-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077851-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077851-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077851-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077851-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077851-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077851-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077851-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077851-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077851-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077851-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077851-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077851-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077851-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077851-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077851-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077851-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077851-002 | AB | 1 | bb7c543d1eb4… |
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 HYDROCHLORIDE | Ascend Laboratories, LLC | 2edc0788-dc38-4d21-ba8e-71f159e2d3b1 | 2026-07-22 | Warnings, Adverse reactions | 077851 ANDA077851 67877-170 67877-169 |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 36592150-7e19-474c-9f96-cc8341e28b5d | 2026-03-20 | Warnings, Adverse reactions | 077851 ANDA077851 |
| Ondansetron | ONDANSETRON | Golden State Medical Supply, Inc. | 2b9ea1fc-59a4-8189-e063-6394a90a9ae6 | 2026-01-27 | Warnings, Adverse reactions | 077851 ANDA077851 |
| Ondansetron | ONDANSETRON | Natco Pharma USA LLC | 64527de5-0b92-4340-9243-7a37e8ff96d9 | 2025-12-19 | Warnings, Adverse reactions | 077851 ANDA077851 69339-172 69339-171 |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | f08f56de-8678-4da9-8cae-013a5c393453 | 2024-10-02 | Warnings, Adverse reactions | 077851 ANDA077851 71335-0132 |
| Ondansetron | ONDANSETRON TABLETS | Natco Pharma Limited | 59c817b7-a1c6-48a5-9bfc-2c381532bfd9 | 2021-11-29 | Warnings, Adverse reactions | 077851 ANDA077851 63850-0004 63850-0003 |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | bde7c22c-0047-4735-8df6-b48e8dfa478a | 2021-01-01 | Warnings, Adverse reactions | 077851 ANDA077851 63187-513 |
| ONDANSETRON | ONDANSETRON | Proficient Rx LP | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 2019-11-01 | Warnings, Adverse reactions | 077851 ANDA077851 63187-065 63187-236 |
| ONDANSETRON | ONDANSETRON | Sun Pharmaceutical Industries, Inc. | 834bc56a-657d-4733-9a60-47040cb5c7bf | 2019-09-11 | Warnings, Adverse reactions | 077851 ANDA077851 63304-458 63304-459 |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 37de0550-a6d1-46a8-a0b8-447b0dcf70ad | 2019-06-12 | Warnings, Adverse reactions | 077851 ANDA077851 71335-0816 71335-0815 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0179-0099 | ondansetron | ondansetron hydrochloride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-0100 | ondansetron | ondansetron hydrochloride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 35356-853 | Ondansetron | Ondansetron | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-853 | Ondansetron | Ondansetron | Lake Erie Medical DBA Qua | ANDA | Current |
| 43063-746 | ondansetron | ondansetron hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-746 | ondansetron | ondansetron hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-746 | ondansetron | ondansetron hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-746 | ondansetron | ondansetron hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-746 | ondansetron | ondansetron hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45963-538 | Ondansetron | Ondansetron | ACTAVIS PHARMA, INC. | ANDA | Current |
| 45963-538 | Ondansetron | Ondansetron | ACTAVIS PHARMA, INC. | ANDA | Current |
| 45963-539 | Ondansetron | Ondansetron | ACTAVIS PHARMA, INC. | ANDA | Current |
| 45963-539 | Ondansetron | Ondansetron | ACTAVIS PHARMA, INC. | ANDA | Current |
| 50090-1600 | ondansetron | ondansetron hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3769 | ONDANSETRON | ONDANSETRON | A-S Medication Solutions | ANDA | Current |
| 50436-0132 | ondansetron | ondansetron hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-0459 | ONDANSETRON | ONDANSETRON | Unit Dose Services | ANDA | Current |
| 51655-400 | Ondansetron HCL | Ondansetron HCL | Northwind Pharmaceuticals | ANDA | Current |
| 51655-800 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Northwind Pharmaceuticals | ANDA | Current |
| 51655-803 | ONDANSETRON | ondansetron hydrochloride | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53002-0570 | Ondansetron | Ondansetron | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0570 | Ondansetron | Ondansetron | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0600 | ondansetron | ondansetron hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0600 | ondansetron | ondansetron hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-300 | ondansetron | ondansetron hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-064 | ONDANSETRON | ONDANSETRON | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-484 | Ondansetron | Ondansetron | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 58118-0450 | ONDANSETRON | ONDANSETRON | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60687-636 | Ondansetron | Ondansetron | American Health Packaging | ANDA | Current |
| 60687-647 | Ondansetron | Ondansetron | American Health Packaging | ANDA | Current |
| 61919-464 | ONDANSETRON | ONDANSETRON | DIRECT RX | ANDA | Current |
| 61919-465 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 63187-065 | ONDANSETRON | ONDANSETRON | Proficient Rx LP | ANDA | Current |
| 63187-065 | ONDANSETRON | ONDANSETRON | Proficient Rx LP | ANDA | Current |
| 63187-236 | ONDANSETRON | ONDANSETRON | Proficient Rx LP | ANDA | Current |
| 63187-236 | ONDANSETRON | ONDANSETRON | Proficient Rx LP | ANDA | Current |
| 63187-513 | ondansetron | ondansetron hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-513 | ondansetron | ondansetron hydrochloride | Proficient Rx LP | ANDA | Current |
| 63304-458 | ONDANSETRON | ONDANSETRON | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-458 | ONDANSETRON | ONDANSETRON | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-459 | ONDANSETRON | ONDANSETRON | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-459 | ONDANSETRON | ONDANSETRON | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63739-333 | Ondansetron | Ondansetron | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-333 | Ondansetron | Ondansetron | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-333 | Ondansetron | Ondansetron | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63850-0003 | Ondansetron | Ondansetron Tablets | Natco Pharma Limited | ANDA | Current |
| 63850-0003 | Ondansetron | Ondansetron Tablets | Natco Pharma Limited | ANDA | Current |
| 63850-0004 | Ondansetron | Ondansetron Tablets | Natco Pharma Limited | ANDA | Current |
| 63850-0004 | Ondansetron | Ondansetron Tablets | Natco Pharma Limited | ANDA | Current |
| 65084-333 | Ondansetron | Ondansetron | McKesson Corporation dba RX Pak | ANDA | Current |
| 67296-1294 | ondansetron | ondansetron | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1294 | ondansetron | ondansetron | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1294 | ondansetron | ondansetron | RedPharm Drug, Inc. | ANDA | Current |
| 67877-169 | ondansetron | ondansetron hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-170 | ondansetron | ondansetron hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 68071-4529 | ondansetron | ondansetron hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-9892 | ondansetron hydrochloride | ondansetron hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9893 | ondansetron hydrochloride | ondansetron hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69339-171 | Ondansetron | Ondansetron | DASH Pharmaceuticals LLC | ANDA | Current |
| 69339-172 | Ondansetron | Ondansetron | DASH Pharmaceuticals LLC | ANDA | Current |
| 70518-0021 | ONDANSETRON | ONDANSETRON | REMEDYREPACK INC. | ANDA | Current |
| 70518-0480 | Ondansetron | Ondansetron | REMEDYREPACK INC. | ANDA | Current |
| 70518-0480 | Ondansetron | Ondansetron | REMEDYREPACK INC. | ANDA | Current |
| 70518-0892 | Ondansetron | Ondansetron | REMEDYREPACK INC. | ANDA | Current |
| 70518-0892 | Ondansetron | Ondansetron | REMEDYREPACK INC. | ANDA | Current |
| 70518-0892 | Ondansetron | Ondansetron | REMEDYREPACK INC. | ANDA | Current |
| 71335-0132 | Ondansetron | Ondansetron | Bryant Ranch Prepack | ANDA | Current |
| 71335-0132 | Ondansetron | Ondansetron | Bryant Ranch Prepack | ANDA | Current |
| 71335-0815 | ondansetron | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0815 | ondansetron | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0816 | ondansetron | ondansetron hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71930-017 | Ondansetron | Ondansetron | Eywa Pharma Inc. | ANDA | Current |
| 71930-017 | Ondansetron | Ondansetron | Eywa Pharma Inc. | ANDA | Current |
| 71930-017 | Ondansetron | Ondansetron | Eywa Pharma Inc. | ANDA | Current |
| 71930-018 | Ondansetron | Ondansetron | Eywa Pharma Inc. | ANDA | Current |
| 71930-018 | Ondansetron | Ondansetron | Eywa Pharma Inc. | ANDA | Current |
| 71930-018 | Ondansetron | Ondansetron | Eywa Pharma Inc. | ANDA | Current |
| 75921-459 | Ondansetron | Ondansetron | Life Line Home Care Services, Inc. | ANDA | Current |
| 80175-0017 | Ondansetron | Ondansetron | Central Packaging | ANDA | Current |
| 80175-0017 | Ondansetron | Ondansetron | Central Packaging | ANDA | Current |