NDC 80425-0228-01 - Ondansetron
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 80425-0228
- Requested NDC
- 80425-0228-01
- Package NDCs from labels
- 80425-0228-1, 80425-0228-2, 80425-0228-3, 80425-0228-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2025-05-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Ondansetron - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2025-05-30 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0228-1 | Ondansetron | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | 6 | |
| 80425-0228-1 | Ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 6 | |
| 80425-0228-2 | Ondansetron | 2 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 2 | 6 | |
| 80425-0228-2 | Ondansetron | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | 6 | |
| 80425-0228-3 | Ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0228 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, 5 package rows | 20240224_f1a0b9ee-c1d2-7818-e053-2995a90a3e96.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0228-1 | EA - Each | 80425-0228 | fa25cf8c-1b2c-4fa0-a25f-e449a12dc055 | 1 | 2023-04-07 |
| 80425-0228-2 | EA - Each | 80425-0228 | be69a6f8-bffd-4c20-b029-ee37c66a28e3 | 1 | 2023-06-06 |
| 80425-0228-3 | EA - Each | 80425-0228 | d416152b-61d5-41ee-b10c-d0ebec5d3c51 | 1 | 2024-03-12 |
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 | Accord Healthcare, Inc. | 35e0d160-813f-41d7-a382-d2cab6485d9c | 2025-10-29 | Warnings, Adverse reactions | 4AF302ESOS |
| Ondansetron | ONDANSETRON | Lifsa Drugs LLC | c66d63cf-a0e5-4cb5-bdf8-9d1115cba23e | 2025-10-13 | Warnings, Adverse reactions | 4AF302ESOS |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 9558d296-8edd-4aa1-875a-6247f9a8374d | 2025-09-15 | Warnings, Adverse reactions | ANDA090469 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 10afd68b-877f-4819-a314-39f2d56d5db9 | 2025-09-15 | Warnings, Adverse reactions | ANDA090469 312087 4AF302ESOS |
| Ondansetron | ONDANSETRON | Preferred Pharmaceuticals, Inc. | b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da | 2025-09-04 | Warnings, Adverse reactions | ANDA090469 312087 4AF302ESOS |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | b50c1767-8a50-49ab-be31-6533021ae7c4 | 2025-08-21 | Warnings, Adverse reactions | ANDA090469 312087 4AF302ESOS |
| Ondansetron | ONDANSETRON | Rising Pharma Holdings, Inc. | eb74425c-c635-4d99-8e98-e63e7359fb89 | 2025-07-17 | Warnings, Adverse reactions | ANDA090469 312087 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | NorthStar Rx LLC | 281e4296-1d0e-4602-9912-2685ba1640f6 | 2025-07-17 | Warnings, Adverse reactions | ANDA090469 312087 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | ee668456-a214-4452-ab9d-ec00eaa41d79 | 2025-07-09 | Warnings, Adverse reactions | ANDA090469 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | Aurobindo Pharma Limited | cab63f24-8728-4927-aba5-53e8d2e44cdb | 2025-07-08 | Warnings, Adverse reactions | ANDA090469 65862-390 312087 104894 aab5d8ee-a492-4deb-b240-62b1b0eb0aa8 cab63f24-8728-4927-aba5-53e8d2e44cdb 4AF302ESOS |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 72f29916-0f95-102d-e053-2991aa0aa5cd | 2025-06-24 | Warnings, Adverse reactions | ANDA090469 312087 4AF302ESOS |
| ondansetron hydrochloride | ONDANSETRON HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 2025-06-12 | Warnings, Adverse reactions | 312087 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | 40d9cc46-aced-4866-812b-7d82933596ae | 2025-06-02 | Warnings, Adverse reactions | 312087 4AF302ESOS |
| ONDANSETRON | ONDANSETRON | Bryant Ranch Prepack | 384a5cfb-05dd-2b79-73f4-a01a47a9eb3e | 2025-06-02 | Warnings, Adverse reactions | 312087 4AF302ESOS |
| Ondansetron | ONDANSETRON | Advanced Rx Pharmacy of Tennessee, LLC | f1a0b9ee-c1d2-7818-e053-2995a90a3e96 | 2025-05-30 | Warnings, Adverse reactions | ANDA090469 80425-0228-2 80425-0228-3 80425-0228-1 80425-0228 80425022801 104894 36624551-9805-e3d9-e063-6294a90aa4f6 f1a0b9ee-c1d2-7818-e053-2995a90a3e96 4AF302ESOS |
| Ondansetron | ONDANSETRON | Asclemed USA, Inc. | e436e361-da0f-7d6d-e053-2995a90a10e4 | 2025-02-21 | Warnings, Adverse reactions | ANDA090469 312087 104894 4AF302ESOS |
| ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | 7b062fa9-e004-23d5-e053-2a91aa0a20cd | 2025-01-08 | Warnings, Adverse reactions | ANDA090469 104894 4AF302ESOS |
| Ondansetron ODT | ONDANSETRON | Advanced Rx of Tennessee, LLC | af836a30-5e51-5c97-e053-2995a90a15b9 | 2024-12-31 | Warnings, Adverse reactions | ANDA090469 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | Advanced Rx Pharmacy of Tennessee, LLC | f1a0ea2c-0788-4e8a-e053-2a95a90a2f32 | 2024-12-31 | Warnings, Adverse reactions | 312087 4AF302ESOS |
| Ondansetron | ONDANSETRON | Advanced Rx Pharmacy of Tennessee, LLC | f1a0cd50-aa4f-55bc-e053-2995a90a2d3a | 2024-12-31 | Warnings, Adverse reactions | 312087 4AF302ESOS |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.