Ondansetron
- Product NDC
- 65862-391
- 11-digit product format
- 658620391
- Labeler code
- 65862
- Product ID
- 65862-391_aab5d8ee-a492-4deb-b240-62b1b0eb0aa8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA090469
- Marketing category
- ANDA
- Marketing start
- 2010-04-12
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090469-001 | ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | |
| A090469-002 | ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090469-001 | AB |
| A090469-002 | 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 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2010-04-12 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-001 | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-002 | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-04-12 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090469-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090469-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090469-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090469-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090469-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090469-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090469-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090469-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090469-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090469-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090469-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090469-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090469-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090469-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090469-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090469-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090469-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090469-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090469-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090469-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090469-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090469-002 | AB | 1 | 74a2ff9319b5… |
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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ONDANSETRON | 8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4AF302ESOS | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cab63f24-8728-4927-aba5-53e8d2e44cdb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9bd4853-037c-6968-f4d4-9bb9a0efd1ea | Product name | 2 | 20250722 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 32e23bc9-ce14-4555-bb6d-bcb654d7d296 | Product name | 1 | 20201015 |
| e459f50a-1553-4aab-b6bd-1e5f0c211c49 | Product name | 1 | 20201015 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 909480fe-0d18-c1c1-a658-0bd9a7131822 | Product name | 5 | 20170829 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-391-01 | Ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 20 | |
| 65862-391-01 | Ondansetron | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | 20 | |
| 65862-391-02 | Ondansetron | 100 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 100 | 20 | |
| 65862-391-05 | Ondansetron | 500 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 500 | 20 | |
| 65862-391-10 | Ondansetron | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | 20 | |
| 65862-391-10 | Ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 20 | |
| 65862-391-30 | Ondansetron | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | 20 | |
| 65862-391-66 | Ondansetron | 6000 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 6000 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-391-10 | EA - Each | 65862-391 | 148fcc64-db16-4186-b972-6af5daf7db42 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Asclemed USA, Inc. | 269c920c-643a-4eea-9bf9-b1f008915db9 | 2026-08-28 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | 66ac9c17-bea7-4f8d-8a27-a1e0f9e65945 | 2026-08-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | 70b48280-ef74-472b-abc3-128962bfcb05 | 2026-08-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 3c4cda2f-13d9-42c5-b449-77deb06c8de5 | 2026-08-03 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | HAWAII REPACK, INC. | b76c5cc9-f1ca-428b-8989-36a66802b650 | 2026-07-17 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 18063a64-a4c0-4bad-911b-00df5c7bb65d | 2026-07-07 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | 77397df5-5a4f-41b2-98bc-f817a1e497fc | 2026-07-02 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 822404ad-af08-4c62-ae38-7d9819e86079 | 2026-07-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | St. Mary's Medical Park Pharmacy | 3207cf04-73b7-24ce-e054-00144ff8d46c | 2026-06-30 | Warnings, Adverse reactions | 090469 ANDA090469 |
| ONDANSETRON | ONDANSETRON | Direct Rx | b38feff2-900a-4e0c-8260-8f090edbc0bc | 2026-03-17 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | A-S Medication Solutions | 378d0963-d026-4478-8202-fbb636904a37 | 2026-02-18 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 9dff6676-e69e-779d-e053-2995a90a7c81 | 2026-01-27 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 76666e7e-3312-6f9d-e053-2991aa0af705 | 2026-01-23 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | f2b502e2-03ed-fe5c-e053-2995a90a368e | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | db9a0d22-9339-4319-e053-2a95a90a9592 | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Northwind Health Company, LLC | e07c38c0-e1c2-01de-e053-2995a90a390a | 2026-01-01 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 9558d296-8edd-4aa1-875a-6247f9a8374d | 2025-09-15 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 10afd68b-877f-4819-a314-39f2d56d5db9 | 2025-09-15 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da | 2025-09-04 | Warnings, Adverse reactions | 090469 ANDA090469 |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | b50c1767-8a50-49ab-be31-6533021ae7c4 | 2025-08-21 | Warnings, Adverse reactions | 090469 ANDA090469 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 2d1b8953-7ff5-4e91-ba97-3ba5c6ea8f71 | 105 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 2d1b8953-7ff5-4e91-ba97-3ba5c6ea8f71 | 105 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | PSN | 378d0963-d026-4478-8202-fbb636904a37 | 39 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 378d0963-d026-4478-8202-fbb636904a37 | 39 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | SCD | 378d0963-d026-4478-8202-fbb636904a37 | 39 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 378d0963-d026-4478-8202-fbb636904a37 | 39 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 10afd68b-877f-4819-a314-39f2d56d5db9 | 25 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 10afd68b-877f-4819-a314-39f2d56d5db9 | 25 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | PSN | cab63f24-8728-4927-aba5-53e8d2e44cdb | 20 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | cab63f24-8728-4927-aba5-53e8d2e44cdb | 20 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | SCD | cab63f24-8728-4927-aba5-53e8d2e44cdb | 20 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | cab63f24-8728-4927-aba5-53e8d2e44cdb | 20 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 18063a64-a4c0-4bad-911b-00df5c7bb65d | 13 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 18063a64-a4c0-4bad-911b-00df5c7bb65d | 13 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da | 11 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da | 11 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 3207cf04-73b7-24ce-e054-00144ff8d46c | 7 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 3207cf04-73b7-24ce-e054-00144ff8d46c | 7 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | f1191e52-982e-49d1-946e-01b469ccedfe | 6 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | b38feff2-900a-4e0c-8260-8f090edbc0bc | 6 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | b38feff2-900a-4e0c-8260-8f090edbc0bc | 6 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | f1191e52-982e-49d1-946e-01b469ccedfe | 6 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | f2b502e2-03ed-fe5c-e053-2995a90a368e | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 76666e7e-3312-6f9d-e053-2991aa0af705 | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 76666e7e-3312-6f9d-e053-2991aa0af705 | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | f2b502e2-03ed-fe5c-e053-2995a90a368e | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 9dff6676-e69e-779d-e053-2995a90a7c81 | 4 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 9dff6676-e69e-779d-e053-2995a90a7c81 | 4 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | c0640556-ae39-4b57-9030-03a23dcdb60c | 3 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | c0640556-ae39-4b57-9030-03a23dcdb60c | 3 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | b50c1767-8a50-49ab-be31-6533021ae7c4 | 2 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 0e62c438-359f-4cec-a785-9c7ac09fa6f8 | 2 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 1eb89f6e-6e01-5812-e054-00144ff88e88 | 2 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | b50c1767-8a50-49ab-be31-6533021ae7c4 | 2 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 1eb89f6e-6e01-5812-e054-00144ff88e88 | 2 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 0e62c438-359f-4cec-a785-9c7ac09fa6f8 | 2 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 238c260b-d7b8-e92a-e063-6394a90a666a | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 238c260b-d7b8-e92a-e063-6394a90a666a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-391-01 | 65862039101 | 1 BLISTER PACK in 1 CARTON (65862-391-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2021-03-24 | 0000-00-00 | No | No | Current |
| 65862-391-02 | 65862039102 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-02) | 2024-04-12 | No | No | Current | ||
| 65862-391-05 | 65862039105 | 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-05) | 2024-04-12 | No | No | Current | ||
| 65862-391-10 | 65862039110 | 3 BLISTER PACK in 1 CARTON (65862-391-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2010-04-12 | 0000-00-00 | No | No | Current |
| 65862-391-30 | 65862039130 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-30) | 2010-04-12 | 0000-00-00 | No | No | Current | |
| 65862-391-66 | 65862039166 | 6000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-66) | 2010-04-12 | 0000-00-00 | No | No | Current |