NDC 80425-0075-01 - Ondansetron HCL
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
- 80425-0075
- Requested NDC
- 80425-0075-01
- Package NDCs from labels
- 80425-0075-4, 80425-0075-1, 80425-0075-3, 80425-0075-2, 80425-0075-5, 80425-0075-01
- Manufacturer
- Advanced Rx 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 HCL - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0075-1 | Ondansetron HCL | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 9 | |
| 80425-0075-2 | Ondansetron HCL | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 9 | |
| 80425-0075-3 | Ondansetron HCL | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 9 | |
| 80425-0075-4 | Ondansetron HCL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 80425-0075-5 | Ondansetron HCL | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0075 | ONDANSETRON HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 5 package rows | 20250101_af75407e-82aa-136f-e053-2995a90a429b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0075-1 | EA - Each | 80425-0075 | 0d0bf3c7-ecec-4e5d-9648-fe3bc130229c | 1 | 2023-04-07 |
| 80425-0075-2 | EA - Each | 80425-0075 | da9ba779-c847-498f-b0e2-d41b38c6f422 | 1 | 2023-04-07 |
| 80425-0075-3 | EA - Each | 80425-0075 | 42e002ba-d6b6-4b43-9f7a-74504858ae62 | 1 | 2023-04-07 |
| 80425-0075-4 | EA - Each | 80425-0075 | 01faaa8b-e11c-4f99-a5b1-e1a966329227 | 1 | 2023-04-07 |
| 80425-0075-5 | EA - Each | 80425-0075 | 18f85afa-0251-4fc9-b432-7a0b0553a587 | 1 | 2023-04-07 |
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 | A-S Medication Solutions | e0f69f57-aeb9-4890-85aa-e5976208e8be | 2026-02-12 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Golden State Medical Supply, Inc. | 2b9ea1fc-59a4-8189-e063-6394a90a9ae6 | 2026-01-27 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | PD-Rx Pharmaceuticals, Inc. | 15d0a711-ef3b-4d93-8fbc-17a45f96af8a | 2026-01-20 | Warnings, Adverse reactions | 312086 NMH84OZK2B |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | Cardinal Health 107, LLC | 30107d6f-5128-484f-b713-65244a98dc67 | 2026-01-14 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | AvPAK | 05cf8d4f-ac57-4177-e063-6394a90ae804 | 2026-01-09 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Glenmark Pharmaceuticals Inc., USA | eee5217a-eba8-463a-812d-bf3c66f0934f | 2026-01-08 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Chartwell Governmental & Specialty RX, LLC. | 7e862601-1d8a-455b-8ce5-1a32478b309f | 2026-01-07 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Chartwell RX, LLC. | 2086bae8-7c3c-4663-93ac-c86407c524c2 | 2026-01-02 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Northwind Health Company, LLC | f76d27c5-acd4-482c-e053-6294a90a5284 | 2026-01-01 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Northwind Health Company, LLC | f29f8ae1-4826-d8eb-e053-2a95a90a691a | 2026-01-01 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Northwind Health Company, LLC | 852a3251-bf28-5557-e053-2991aa0a4fbd | 2026-01-01 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Northwind Health Company, LLC | db99c77a-0b01-9da6-e053-2a95a90a5199 | 2026-01-01 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Redpharm Drug | 300b1916-a3d8-0220-e063-6394a90a6f55 | 2025-12-23 | Warnings, Adverse reactions | 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Natco Pharma USA LLC | 64527de5-0b92-4340-9243-7a37e8ff96d9 | 2025-12-19 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | QPharma, Inc. | fbe71308-2927-2467-e053-6394a90aa419 | 2025-12-16 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | QPharma, Inc. | 2fa30bdb-f60e-40a7-98b4-c346bc85d539 | 2025-12-15 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | QPharma, Inc. | dafe875e-391f-47a2-97b7-89840a760e44 | 2025-12-15 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Hospira, Inc. | e0862c02-781f-4b10-ae50-9c9c4ca26f6d | 2025-12-01 | Warnings, Adverse reactions | NMH84OZK2B |
| ondansetron hydrochloride | ONDANSETRON HYDROCHLORIDE | Onesource Specialty Pharma Limited | 438c3d28-8bed-50f0-e063-6394a90a18e4 | 2025-11-14 | Warnings, Adverse reactions | NMH84OZK2B |
| ondansetron hydrochloride | ONDANSETRON HYDROCHLORIDE | Onesource Specialty Pharma Limited | a5fe05bc-a7a5-4131-8c4d-2edd113441ec | 2025-11-14 | Warnings, Adverse reactions | NMH84OZK2B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.