NDC 80425-0227-01 - 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
- 80425-0227
- Requested NDC
- 80425-0227-01
- Package NDCs from labels
- 80425-0227-1, 80425-0227-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- 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 | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0227-1 | Ondansetron | 10 in 1 BOTTLE, UNIT-DOSE | TABLET, ORALLY DISINTEGRATING | 10 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0227 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250102_f1a0cd50-aa4f-55bc-e053-2995a90a2d3a.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0227-1 | EA - Each | 80425-0227 | 6b0b97f9-0549-4145-81d9-0939a1e667a5 | 1 | 2023-06-06 |
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 | Gland Pharma Limited | 3efa5604-96c3-42a0-8e99-b3de4a66aa92 | 2025-07-31 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PHOENIX RX LLC | 3a76bae2-04c2-ee2d-e063-6394a90ad4c8 | 2025-07-21 | Warnings, Adverse reactions | 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Aurobindo Pharma Limited | 57578387-1918-4e56-a564-f14fb22340bf | 2025-07-19 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Rising Pharma Holdings, Inc. | eb74425c-c635-4d99-8e98-e63e7359fb89 | 2025-07-17 | Warnings, Adverse reactions | 312087 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | NorthStar Rx LLC | 281e4296-1d0e-4602-9912-2685ba1640f6 | 2025-07-17 | Warnings, Adverse reactions | 312087 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | ee668456-a214-4452-ab9d-ec00eaa41d79 | 2025-07-09 | Warnings, Adverse reactions | 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON HYDROCHLORIDE | Aurobindo Pharma Limited | cf10d256-dd89-4a91-a3ed-81db505a79c2 | 2025-07-08 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Aurobindo Pharma Limited | cab63f24-8728-4927-aba5-53e8d2e44cdb | 2025-07-08 | Warnings, Adverse reactions | 312087 104894 4AF302ESOS |
| ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Dr. Reddy's Laboratories Limited | 162f2088-9fb1-47e7-b88c-45104be7e7bb | 2025-06-30 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Baxter Healthcare Corporation | 729d865f-d84a-495e-9456-4bceebb6e03f | 2025-06-30 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals,Inc. | 72f29916-0f95-102d-e053-2991aa0aa5cd | 2025-06-24 | Warnings, Adverse reactions | 312087 4AF302ESOS |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | ee1f115f-c8f8-4526-b827-c8e48aeb5050 | 2025-06-20 | Warnings, Adverse reactions | NMH84OZK2B |
| ondansetron hydrochloride | ONDANSETRON HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 2025-06-12 | Warnings, Adverse reactions | 312086 198052 312087 104894 4AF302ESOS NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 1a0c4dc6-643e-4ee7-92a9-edb98049a5ba | 2025-06-09 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | 40d9cc46-aced-4866-812b-7d82933596ae | 2025-06-02 | Warnings, Adverse reactions | ANDA078152 312087 4AF302ESOS |
| ONDANSETRON | ONDANSETRON | Bryant Ranch Prepack | 384a5cfb-05dd-2b79-73f4-a01a47a9eb3e | 2025-06-02 | Warnings, Adverse reactions | 198052 312087 4AF302ESOS |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Precision Dose Inc. | 04800a86-2391-44e6-8763-d65e8a916c26 | 2025-05-30 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Advanced Rx Pharmacy of Tennessee, LLC | f1a0b9ee-c1d2-7818-e053-2995a90a3e96 | 2025-05-30 | Warnings, Adverse reactions | 104894 4AF302ESOS |
| Ondansetron | ONDANSETRON | ATLANTIC BIOLOGICALS CORP. | e5ab38a2-5921-4320-a313-e0080c078046 | 2025-05-28 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | NuCare Pharmaceuticals, Inc. | 2eeb3c61-4ce9-d8ed-e063-6294a90a00d3 | 2025-02-24 | Warnings, Adverse reactions | 312086 NMH84OZK2B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.