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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078539-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-07-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078539-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-07-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078539-003 | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET / ORAL | 2007-07-31 | c2088c7a36db… | ||
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078539-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078539-002 | AB | 1 | c2088c7a36db… |
| 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… |
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 | Northwind Health Company, LLC | f76d27c5-acd4-482c-e053-6294a90a5284 | 2026-01-01 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Northwind Health Company, LLC | f29f8ae1-4826-d8eb-e053-2a95a90a691a | 2026-01-01 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Northwind Health Company, LLC | 852a3251-bf28-5557-e053-2991aa0a4fbd | 2026-01-01 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Northwind Health Company, LLC | db99c77a-0b01-9da6-e053-2a95a90a5199 | 2026-01-01 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | QPharma, Inc. | fbe71308-2927-2467-e053-6394a90aa419 | 2025-12-16 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | QPharma, Inc. | 2fa30bdb-f60e-40a7-98b4-c346bc85d539 | 2025-12-15 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | QPharma, Inc. | dafe875e-391f-47a2-97b7-89840a760e44 | 2025-12-15 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PHOENIX RX LLC | 3a79fc2b-9ea3-a808-e063-6394a90ae794 | 2025-09-22 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PHOENIX RX LLC | 40106070-6a25-5b0e-e063-6394a90a4197 | 2025-09-22 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 0b675b09-fe40-435c-b91a-c61cdf767fbf | 2025-09-15 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 36d64400-2d13-4a1a-a1ca-4741cd3d3f1a | 2025-09-03 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron | ONDANSETRON | NorthStar Rx LLC | 9d5e7650-95be-4b96-b29c-374f673eb7a1 | 2025-09-03 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 90e0e508-75f7-4c8b-bb38-898aa4c531c3 | 2025-09-01 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 426ba54f-199a-41d1-8c27-f827bea56854 | 2025-08-15 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PHOENIX RX LLC | 3a76bae2-04c2-ee2d-e063-6394a90ad4c8 | 2025-07-21 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Aurobindo Pharma Limited | 57578387-1918-4e56-a564-f14fb22340bf | 2025-07-19 | Warnings, Adverse reactions | 078539 ANDA078539 65862-189 65862-188 65862-187 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals, Inc. | 2eeb3c61-4ce9-d8ed-e063-6294a90a00d3 | 2025-02-24 | Warnings, Adverse reactions | 078539 ANDA078539 |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | f8ada0e4-5c1b-17ab-e053-6294a90a12b8 | 2025-02-06 | Warnings, Adverse reactions | 078539 ANDA078539 |
| 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 68071-2053 |
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 |
|---|---|---|---|---|---|
| 60760-637 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-637 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-637 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-637 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-637 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | DIRECT RX | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | DIRECT RX | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | DIRECT RX | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-087 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-565 | ONDANSETRON | ONDANSETRON | DIRECT RX | ANDA | Current |
| 61919-565 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-565 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-565 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-565 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 61919-565 | ONDANSETRON | ONDANSETRON | Direct_Rx | ANDA | Current |
| 63187-636 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-636 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-636 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-636 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-709 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-709 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-709 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-709 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-7781 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7781 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7781 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7938 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8111 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8111 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 65862-187 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-187 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-187 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-187 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-188 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-188 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-188 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-188 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-189 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-189 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-189 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-189 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 66116-604 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | MedVantx, Inc. | ANDA | Current |
| 67046-346 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0902 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0902 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0902 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1562 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1562 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1562 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1816 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1816 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1816 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2053 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2053 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2053 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2147 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2147 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2855 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4206 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4206 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4208 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4208 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4328 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 68071-4328 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 68071-4328 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 68071-4705 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4705 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4966 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NUCARE PHARMACEUTICALS INC | ANDA | Current |
| 68071-4966 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NUCARE PHARMACEUTICALS INC | ANDA | Current |
| 68071-5047 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5047 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-220 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-220 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-220 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-220 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | American Health Packaging | ANDA | Current |